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2022+多学会共识指南:胃食管反流病的治疗
2023-03-02 | 阅:  转:  |  分享 
  
Vol.:(0123456789)1 3

Surgical Endoscopy

https://doi.org/10.1007/s00464-022-09817-3

GUIDELINES

and Other Interventional Techniques

Multi-society consensus conference anduni00A0guideline onuni00A0theuni00A0treatment

ofuni00A0gastroesophageal reflux disease (GERD)

Bethanyuni00A0J.uni00A0Slater

1

uni00A0· Ameliauni00A0Collings

2

uni00A0· Rebeccauni00A0Dirks

2

uni00A0· Jonuni00A0C.uni00A0Gould

3

uni00A0· Aliauni00A0P.uni00A0Qureshi

4

uni00A0· Ryanuni00A0Juza

5

uni00A0·

Maríauni00A0Ritauni00A0Rodríguez-Luna

6

uni00A0· Claireuni00A0Wunker

7

uni00A0· Geof_freyuni00A0P.uni00A0Kohn

8

uni00A0· Shanuuni00A0Kothari

9

uni00A0· Elizabethuni00A0Carslon

10

uni00A0·

Stephanieuni00A0Worrell

11

uni00A0· Ahmeduni00A0M.uni00A0Abou-Setta

12

uni00A0· Mohammeduni00A0T.uni00A0Ansari

13

uni00A0· Dimitriosuni00A0I.uni00A0Athanasiadis

2

uni00A0· Shaununi00A0Daly

14

uni00A0·

Francescauni00A0Dimou

15

uni00A0· Ivyuni00A0N.uni00A0Haskins

16

uni00A0· Julieuni00A0Hong

17

uni00A0· Kumaruni00A0Krishnan

18

uni00A0· Anneuni00A0Lidor

5

uni00A0· Virginiauni00A0Litle

19

uni00A0· Donalduni00A0Low

10

uni00A0·

Anthonyuni00A0Petrick

20

uni00A0· Ianuni00A0S.uni00A0Soriano

21

uni00A0· Niravuni00A0Thosani

22

uni00A0· Amyuni00A0Tyberg

23

uni00A0· Vicuni00A0Velanovich

24

uni00A0· Ramonuni00A0Vilallonga

25

uni00A0·

Jef_freyuni00A0M.uni00A0Marks

26

Received: 29 August 2022 / Accepted: 2 December 2022

? The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022

Abstract

Background Gastroesophageal reflux disease (GERD) is one of the most common diseases in North America and globally.

The aim of this guideline is to provide evidence-based recommendations regarding the most utilized and available endoscopic

and surgical treatments for GERD.

Methods Systematic literature reviews were conducted for 4 key questions regarding theuni00A0surgical and endoscopic treatments

for GERD in adults: preoperative evaluation, endoscopic vs surgical or medical treatment, complete vs partial fundoplica-

tion, and treatment for obesity (body mass index [BMI] uni2265 35uni00A0kg/m

2

) and concomitant GERD. Evidence-based recommenda-

tions were formulated using the GRADE methodology by subject experts. Recommendations for future research were also

proposed.

Results The consensus provided 13 recommendations. Through the development of these evidence-based recommenda-

tions, anuni00A0algorithm was proposed for aid in the treatment of GERD. Patients with typical symptoms should undergo upper

endoscopy, manometry, and pH-testing; additional testing may be required for patients with atypical or extra-esophageal

symptoms. Patients with normal or abnormal findings on manometry should consider undergoing partial fundoplication.

Magnetic sphincter augmentation or fundoplication are appropriate surgical procedures for adults with GERD. For patients

who wish to avoid surgery, the Stretta procedure and transoral incisionless fundoplication (TIF 2.0) were found to have bet-

ter outcomes than proton pump inhibitorsuni00A0alone. Patients with concomitant obesity were recommended to undergo either

gastric bypass or fundoplication, although patients with severe comorbid disease or BMI > 50 should undergo Roux-en-Y

gastric bypass for the additional benefits that follow weight loss.

Conclusion Using the recommendations an algorithm was developed by this panel, so that physicians may better counsel

their patients with GERD. There are certain patient factors that have been excluded from included studies/trials, and so

these recommendations should not replace surgeon–patient decision making. Engaging in the identified research areas may

improve future care for GERD patients.

Keywords Antireflux surgeryuni00A0· Fundoplicationuni00A0· Gastroesophageal refluxuni00A0· GERDuni00A0· Obesityuni00A0· Proton pump inhibitor

Abbreviations

ARM Anti-reflux medication

ARS Anti-reflux surgery

CI Confidence interval

EGD Esophagogastroduodenoscopy

MSA Magnetic sphincter augmentation

GERD Gastroesophageal reflux disease

GRADE Grading of Recommendations Assess-

ment, Development and Evaluation

HREM High-resolution esophageal

manometry

KQ Key question

PRISMA Preferred Reporting Items for System-

atic Reviews and Meta-Analyses

Bethany J. Slater and Amelia Collings are co-first authors.

Bethany J. Slater

bjslater1@gmail.com

Extended author information available on the last page of the article

Surgical Endoscopy

1 3

QoL Quality of life

PPI Proton pump inhibitor

LES Lower esophageal sphincter

LA Los Angeles

Stretta procedure Radiofrequency treatment for GERD

RCT Randomized clinical trial

TIF Transoral incisionless fundoplication

RYGB Roux-en-Y gastric bypass

LNF Laparoscopic Nissen Fundoplication

GERD is defined as a disease associated with symptoms and/

or complications due to the reflux of stomach contents into

the esophagus [2]. GERD is one of the most common dis-

eases in North America and the world, typically presenting

with heartburn and regurgitation, often responsive to proton

pump inhibitor therapy (PPI) [2]. While there is considerable

geographical variation of GERD, the general prevalence in

North America ranges from 18.1 to 27.8%, in Europe 8.8 to

25.9%, in the Middle East 8.7 to 33.1%, in East Asia 2.5 to

7.8%, and 11.6 to 23.0% in Australia [3]. Due to its increas-

ing prevalence, the widespread burden of disease carries

both a financial and resource cost. In addition to its societal

implications, GERD also adversely impacts patients’ quality

of life (QoL) [4].

The topics addressed in this guideline, and the associ-

ated recommendations, are divided into four key questions

(KQ). The first key question (KQ1) is about the identifica-

tion of patients who will benefit most from surgical and or

endoscopic treatment of GERD. The symptoms and patho-

physiology of GERD can vary significantly, and response to

treatment is not always equal. Although medical treatment

(predominantly with proton pump inhibitor (PPI) medica-

tions) is the least invasive and most common modality for

treating GERD, adverse side effect such as nutritional defi-

ciencies, infectious diseases, and risk of osteoporosis leading

to increased fractures have been reported [5]. Additionally,

25–42% of patients are partially or completely unrespon-

sive to medical therapy [6]. In these medically refractory

patients, as well as in patients who desire to not be on life-

long medication, laparoscopic anti-reflux surgery (ARS) is

highly effective in controlling reflux symptoms long-term

[7]. Careful patient selection is essential in the diagnosis and

workup of patients with symptomatic GERD and is neces-

sarily reliant on quality of preoperative testing. Currently, no

consensus is yet established to direct preoperative workup

to reduce unnecessary testing while ensuring optimal post-

operative outcomes following ARS.

Multiple surgical techniques and procedures are

employed depending on pre-operative testing and sur-

geon preference. Often these surgeries involve creating

an anti-reflux barrier using a portion of the stomach. A

newer surgical technique, however, is magnetic sphincter

augmentation (MSA) which recreates a reflux barrier using

a set of magnetic beads. While successful in the long term,

the level of invasiveness precludes this from being first

line therapy for all patients. To minimize the invasiveness

while maintaining medication free treatment, endoscopic

therapies have also been developed including Transoral

Incisionless Fundoplication (TIF) and radiofrequency

treatment for GERD (Stretta procedure). Comparisons

of the surgical, endoscopic, and medical treatments are

addressed in key question two (KQ 2).

Multiple surgical techniques and procedures are employed

to control GERD symptoms. The choice of which type of

fundoplication (complete versus partial) is based on many

variables including pre-operative testing, esophageal func-

tion, patient’s pre-operative symptoms, and surgeon prefer-

ence. Some surgeons believe that a partial fundoplication

offers inferior symptom control with decreased post-opera-

tive adverse side effects, while other surgeons argue that the

two surgeries have similar rates of symptom resolution [8,

9]. There continues to be significant debate regarding com-

parison of routine use of Nissen fundoplication to a partial

fundoplication or tailored approach with numerous meta-

analyses and review articles addressing this issue. [8–11]

This debate stems in part from the fact that there are no

uniform techniques across surgeons. Key question three (KQ

3) addresses the data comparing outcomes after complete

versus partial fundoplication for all patients and specifically

those with pre-operative dysphagia.

Morbid obesity, defined as a body mass index

(BMI) uni2265 35uni00A0kg/m

2

, remains endemic in the USA and Europe.

Interestingly, the increased prevalence of morbid obesity

and GERD in the USA and Europe seem to parallel one

another, suggesting that these two processes may be inti-

mately associated with one another [12, 13]. In fact, it is

estimated that morbidly obese patients are 2.5 times more

likely to experience GERD symptoms relative to their non-

obese counterparts [12]. The question of the ideal proce-

dure for patients with pathologically proven GERD, who

also suffer from clinically severe obesity, is the focus of key

question 4 (KQ4). While traditional anti-reflux procedures

focus on augmenting or increasing the barrier to reflux at

the esophagogastric junction, Roux-en-Y Gastric Bypass

(RYGB) leads to GERD resolution through exclusion of the

acid producing cells in the bypassed portion of the stomach

while also reducing the risk of bile reflux. Both approaches

bring their own unique set of advantages and disadvantages.

The purpose of KQ4 is to determine the procedure of choice

(RYGB versus laparoscopic Nissen fundoplication (LNF))

to address medically refractory GERD in patients who suf-

fer from clinically severe morbid obesity as well as which

of these procedures is best for a failed prior fundoplication

(redo fundoplication versus conversion to RYGB). Addi-

tionally, GERD prevalence may also be affected by sleeve

Surgical Endoscopy

1 3

gastrectomy, especially due to the risk of de novo or possibly

exacerbating pre-existing GERD symptoms [14].

The aim of this guideline is to provide evidence-based

recommendations regarding the most utilized and available

endoscopic and surgical treatments for gastroesophageal

reflux disease (GERD). The purpose is to create a proposed

algorithm that standardizes the workup, diagnosis, and

treatment of a patient with suspected GERD and to develop

and disseminate evidence-based practice guidelines for the

management of GERD. By standardizing care for patients

using the best available evidence, higher quality care can

be achieved.

Methods

The guideline panel determined the certainty of evidence,

and the direction and strength of recommendations, with

the widely used Grading of Recommendations Assessment,

Development and Evaluation (GRADE) approach[1, 15,

16] using the GRADE guideline development tool [17, 18].

Reporting of the guideline adheres to the Essential Report-

ing Items for Practice Guidelines in Healthcare (RIGHT)

checklist [18]. Evidence addressing the guideline ques-

tions was synthesized according to the SAGES Guidelines

Committee’s standard operating procedure [19]. PubMed,

Embase, Cochrane, Clinicaltrials.gov, International Clini-

cal Trials Platform (ICTRP), and Google Scholar databases

were searched (1947–2021) to identify randomized control

trials and non-randomized comparative studies (Supplement

1). When there was a paucity of retrieved evidence for a

question, experts included non-comparative evidence in their

systematic reviews.

Two independent reviewers screened retrieved records for

eligibility. Screening criteria and “Preferred Reporting Items

for Systematic Reviews and Meta-Analyses (PRISMA)”

screening flow diagrams for each KQ are provided in Sup-

plement 3. Study quality was assessed using the Cochrane

Risk of Bias and Newcastle Ottawa Scale. Random effects

meta-analysis was performed on available comparative data.

Guideline panel organization

International expert surgeons and gastroenterologists devel-

oped the evidence-based guideline recommendations. The

panel was composed of members from the Society of Ameri-

can Gastrointestinal and Endoscopic Surgery (SAGES),

American Society for Gastrointestinal Endoscopy (ASGE),

American Society for Metabolic and Bariatric Surgery

(ASMBS), European Association for Endoscopic Sur-

gery (EAES), Society for Surgery of the Alimentary Tract

(SSAT), and The Society of Thoracic Surgeons (STS).

A methodologist with guideline development expertise

(M.T.A.) and the SAGES Guidelines Committee Fellow

(A.C.) facilitated guideline panel meetings as non-voting

members of the panel.

Guideline funding & declaration anduni00A0management

ofuni00A0competing interests

Funding for the methodologists, the librarian, and partial

salary support for the fellow were provided by SAGES.

The consensus conference is supported by all six project

partners, SAGES, ASMBS, ASGE, STS, SSAT, and EAES.

The organizations committed to help fund this conference

and have provided staff support and meeting space at their

respective meetings for the conference preparation and plan-

ning. All disclosed potential conflicts of interest are listed

in Supplement 2.

Selection ofuni00A0questions anduni00A0outcomes ofuni00A0interest

The preoperative workup and use of surgical/endoscopic

treatment for GERD are the focus of this guideline. The

final set of question-specific outcomes were selected by sim-

ple majority. Some outcomes, such as QoL, have multiple

metrics, thus a standardized effect was used.

Under the guidance of the steering committee (J.M., J.G.,

A.Q., and B.S.) and guideline methodologist, each group of

experts created a list of KQs relating to their specific aspect

of GERD using the PICO format (patient-intervention-com-

parator-outcome). Outcomes “critical” or “important” to

decision making for these KQs were defined and reviewed.

Given their long-standing experience with patients, panel

members provisionally identified question specific patient-

centered outcomes that they felt most patient-surgeon dyads

would consider important or critical for decision making

(Tableuni00A01). The importance of these outcomes was re-visited

by panel members during the formulation of recommenda-

tions after they had reviewed the systematic review evidence.

Screening criteria and Preferred Reporting Items for Sys-

tematic Reviews and Meta-Analyses (PRISMA) figures for

each KQ found in Supplement 3.

Determining theuni00A0certainty ofuni00A0evidence

Methods outlined in the Grading of Recommendations

Assessment, Development and Evaluation (GRADE)

approach handbook were used to judge the certainty of evi-

dence for each outcome of interest [20]. GRADEPro evi-

dence tables were created. The highest level of data avail-

able was used for tables, less rigorous data that addressed

the same outcomes was considered but not used in decision

making. In brief, the guidelines systematic review working

group judged the certainty of the body of evidence across the

domains of risk of bias across, inconsistency, indirectness,

Surgical Endoscopy

1 3

imprecision, and publication bias if > 10 studies were avail-

able. If there was concern in any one of these domains, the

certainty was downgraded. This data was then imported into

the Evidence to Decision (EtD) table for each KQ. The EtD

tables serve as a framework through which the final recom-

mendations are developed.

Data from these studies were not used in the development

of recommendations, but only used for supporting evidence

during the discussion of the summary of the evidence.

Assumed values anduni00A0preferences

As this guideline took a patient-centered perspective, rather

than a societal perspective, the panel members used their

collective patient experience to determine judgements about

patient values and preferences. The panel members recog-

nized that patients may vary in what value they place on an

outcome when coming to a clinical decision. Patients were

not included in panel discussion and thus physician panel

members used their experience as a surrogate for determin-

ing patient preferences. The proposed target audience of this

guideline are patients and their physicians, both surgeons

and gastroenterologists.

Development ofuni00A0recommendations

Panel members were provided with the articles and the

results of the systematic review created specifically for the

Table 1 Importance of

outcomes by working group

Group Outcome Importance

Group 1 Abnormal Findings Critical

Change in Intervention Critical

Group 2 Patient reported reflux symptom resolution-

(within 2uni00A0year)

Critical

Need for anti-reflux medication (PPI only) Critical

Quality of life Scale-

Short-term (< 2uni00A0year) and Long-term (uni2265 2uni00A0year)

Critical

Patient reported reflux symptom recurrence-

Short-term (< 2uni00A0year) and Long-term (uni2265 2uni00A0year)

Critical

Dysphagia—requiring intervention Important

Hiatal hernia recurrence (uni2265 3uni00A0cm and symptomatic) Important

Patient satisfaction Important

Dysphagia—patient reported-

(> 3mon and uni2264 3 mon)

Important

Perioperative complications (< 30d)-

Clavien Dindo uni2265 2

Important

Objectively established reflux recurrence Not important

Perioperative mortality (< 30uni00A0day) Not important

Reoperation Not important

Cost Not important

Group 3 Patient reported reflux symptom resolution Critical

Objective reflux recurrence Critical

Dysphagia requiring intervention Critical

Hiatal hernia recurrence Important

Gas/bloat/Inability to Vomit Important

Group 4 Patient reported reflux symptom resolution (< 2uni00A0year) Critical

Patient reported symptom recurrence –

short term (< 2uni00A0year) and long term (> 2uni00A0year)

Critical

Objectively established reflux recurrence Critical

Progression to Barrett’s esophagus Critical

Perioperative complications (< 30uni00A0days)–

Clavien Dindo uni2265 2

Important

Perioperative Mortality (< 30uni00A0days) Important

Reoperation Important

Dysphagia—requiring intervention Important

Hiatal hernia recurrence (uni2265 3uni00A0cm &/or symptomatic) Not important

Need for anti-reflux medication (PPI or H2B) Not important

Surgical Endoscopy

1 3

guideline and pertinent to a KQ in advance of the meetings.

During panel meetings, the group reviewed the GRADE

evidence profile and summary of findings tables, completed

the Evidence-to-Decision (EtD) tables, and generated pro-

visional recommendations. A multi-society conference was

held at the SAGES 2021 annual meeting. After presenting

the data and audience discussion, participants voted on the

proposed recommendations. Consensus conference voting

led to minor changes in the recommendations.

Outcomes from the Evidence Tables were imported into

GRADEPro EtD tables. To determine the direction of a rec-

ommendation (i.e., for or against the intervention vs. the

comparator) and its strength (i.e., strong or conditional) in

light of the synthesized evidence, the panel deliberated upon

various EtD criteria such as the magnitude of desirable and

undesirable effects, the overall certainty of evidence, vari-

ation in values that may be assigned to outcomes, and the

balance of these effects. The panel also discussed accept-

ability and feasibility considerations for implementing the

recommendation. Additional considerations taken either

from panel expert experience or interpretation of evidence

were noted.

A strong recommendation would be made if high cer-

tainty evidence demonstrated that benefits would clearly

outweigh harms for almost all patients in general, or for a

subgroup of patients with no serious implications related

to acceptability and feasibility of the recommendation. A

conditional recommendation would be made when there is

important variability in patient values and preferences for

outcomes such that the balance of benefits and harms is

likely to differ for a substantial proportion of patients, the

balance between desirable and undesirable consequences is

close, or when the overall certainty of evidence is judged

low.

Subgroups were further addressed in discussion for the

justification for each recommendation and are specified for

each KQ below. Full evidence to decision tables are pre-

sented in Supplement 4–6 and summarized in the following

recommendations. While serial voting was used to come to a

consensus on individual criteria of the EtD, a supermajority,

defined as 80% panel agreement, was used as the cut-off for

formulating recommendations [21].

Guideline document review

This guideline was reviewed and edited by all panel mem-

bers. Each KQ was developed by a subgroup and then

reviewed by the entire group for completeness and accu-

racy. The revised draft was distributed to the full consensus

committee. After incorporating these edits, the final guide-

line was then submitted to the SAGES Executive Board for

approval and published online on its website (www. sages.

org) for public comment for additional quality assurance.

In addition, for external review, the manuscript was sent to

the SAGES Guidelines Quality Assurance Task Force not

involved in the guidelines process to minimize the introduc-

tion of bias in the recommendations.

Key questions

Key Question 1 (KQ1): What studies are necessary for

preoperative evaluation of adults

with GERD?

Key Question 2 (KQ2): Should endoscopic, surgical, or

medical treatment be used in adult

patients with GERD?

Key Question 3 (KQ3): Should complete or partial fun-

doplication be used in adult

patients with GERD?

Key Question 4 (KQ4): What is the best treatment for adult

patients with obesity (BMI uni2265 35)

and concomitant GERD?

(KQ1) What studies are necessary for preoperative evalu-

ation of adult patients with GERD?

Recommendation

The panel suggests esophagogastroduodenoscopy (EGD),

manometry, and pH testing for all patients with esophageal

symptoms of medically refractory reflux undergoing pre-

operative evaluation; however, patients with Los Angeles

(LA) grade C or D erosive esophagitis on endoscopy may

not require pH testing to confirm the diagnosis of GERD.

(Expert Opinion; GRADE recommendation was unable to

be determined due to lack of evidence).

The panel suggests that patients with extra-esophageal

GERD symptoms or equivocal findings on essential test-

ing require more diligent workup (Expert Opinion; GRADE

recommendation was unable to be determined due to lack

of evidence).

Summary ofuni00A0theuni00A0evidence

No direct comparative evidence addressed this question.

Qualitative indirect comparisons could also not be made as

studies were not designed as diagnostic test evaluations, dif-

fered in patient populations, and employed varying GERD

severity measurement metrics (e.g., pH, manometric meas-

ures, and impedance). As such, expert opinion was generated

based on the following data.

Surgical Endoscopy

1 3

Our systematic review of the literature resulted in 34

observational studies that examined the use of the preopera-

tive studies of interest [22–55]. There were no randomized

clinical trials (RCTs) available. In total, there were 7,025

patients included between the sum of these studies. There

were a total of 4,586 patients across 26 studies who under-

went preoperative pH-monitoring [22–29, 31, 32, 35, 37, 38,

40–47, 49–51, 53, 56]. Of those studies that reported specific

pH results, 2474 patients out of 4,803 patients (51.5%) had

abnormal findings. A single study reported a change in their

planned intervention for 41.8% of patients based on the find-

ings from pH-monitoring (Tableuni00A02) [23].

There were 28 studies that reported using manometry in

the preoperative work up of 5,807 GERD patients [22–29,

32, 34, 36–38, 40, 40, 41, 41, 42, 42, 43, 43, 44, 44, 45, 45,

46, 46, 47, 47, 48, 48, 49, 49, 50, 50, 51, 51, 55, 57]. Of

those studies, there were 16 that reported on specific mano-

metric findings. These studies observed abnormal peristalsis

in 1,251 out of 4,303 (29.1%) GERD patients. Nine studies

that reported that 17.3% (149 patients out of 860 patients)

had a change in intervention based on manometric findings

(Tableuni00A02). Most commonly, this was a change from a planned

complete fundoplication to a partial fundoplication.

There were only six studies that used impedance testing

preoperatively in 511 patients with GERD [31, 39, 42, 54,

55, 57]. Four studies described specific findings observing

that 9.3% of patients had abnormal findings. Two studies

reported that 45 patients had a change from the planned

intervention out of 221 that underwent impedance testing

[31, 39]. There were no studies that addressed the findings

on impedance testing and the need for surgery. Lastly, 26

studies evaluated 4188 GERD patients with preoperative

endoscopy, of which 76.8% had abnormal findings, most

commonly esophagitis [22–27, 31, 32, 35, 37–42, 44–52,

54]. There were no studies that reported on a change in inter-

vention based on endoscopic findings (Tableuni00A02).

Decision criteria anduni00A0additional considerations

With healthcare costs rising, effective disease diagnosis

must take into consideration both efficiency and costs in

the measure of quality. Determining the workup strategy

that optimizes these factors is paramount. While unnec-

essary tests increase cost, the omission of necessary tests

can have equally deleterious outcomes and financial reper-

cussions. Based on our review of the available literature,

EGD, manometry, and pH-testing are essential components

of the diagnostic workup for patients with typical esopha-

geal GERD symptoms, i.e., heartburn and/or regurgitation.

This is based on available information that the majority of

patients with typical GERD symptoms will derive clini-

cal benefit from ARS with a low rate of complications.

Manometry is used to rule out other motility disorders such

as achalasia. For patients with atypical or extra-esophageal

GERD symptoms such as cough, throat clearing, chest pain,

or hoarseness, additional workup including pH/impedance

testing should be employed, in addition to possible referral

to other specialty providers as determined by the physician.

Research recommendations

Preoperative workup, key diagnostic criteria as well as ter-

minology should be standardized to improve diagnostic out-

put and direct future research. The panel agreed that there is

a tremendous need for standardized terminology across dis-

ciplines, among surgeons, gastroenterologists, and radiolo-

gists to facilitate better understanding, communication, and

to guide future research. Written documentation of endo-

scopic findings including Hill grade of the LES, esophageal

length, and location of diaphragmatic pinch as well as lib-

eral photo documentation will aid in standardized care of

patients with GERD across different physician disciplines.

Once there is better classification of patients during their

pre-operative workup phase, surgical treatment can be more

accurately tailored to the specific patient.

Newer technologies of GERD testing such as high-reso-

lution esophageal manometry (HREM), endo-FLIP, or solid

phase upper gastrointestinal study (Marshmallow-Bagel)

may be indicated to better evaluate patients prior to offering

ARS. High-resolution esophageal manometry is an exam-

ple of technology outpacing surgical literature. Although

regarded as a more accurate measure of esophageal function,

without rigorous clinical data to direct choice of surgical

wrap, HREM is limited in its capacity to guide effective

treatment despite the higher quality data produced.

(KQ2) Should endoscopic, surgical, or medical treatment

be used in adult patients with GERD?

2a. Should treatment with MSA versus fundoplication be

used for patients with GERD?

Recommendation

The panel suggests that adult patients with GERD may be

treated with either MSA or Nissen fundoplication based on

Table 2 Summary of Evidence for Key Question 1

Workup

modality

Number

of stud-

ies

Number of

patients get-

ting study

%

Abnormal

findings

% Change in

intervention

pH testing 26 4586 51.5 41.8

Manometry 28 5807 29.1 17.3

Impedance 6 511 9.3 20.4

EGD 26 4188 76.8 0

Surgical Endoscopy

1 3

surgeon and patient shared decision making (conditional

recommendation, very low certainty evidence).

Summary ofuni00A0theuni00A0evidence

From 74 studies included in the systematic review, nine

short-term observational studies were included for the panel

discussion to form the final recommendation [58–66]. There

was no informative data for hiatal hernia recurrence, objec-

tive reflux recurrence, and peri-operative mortality. (See

evidence profile in the EtD framework, Supplement 4) All

included studies compare MSA to only Nissen fundoplica-

tion and not any other wrap types.

Benefits ofuni00A0theuni00A0intervention

There were five outcomes with desirable effects for MSA

as compared to Nissen fundoplication including symptom

recurrence, complications, re-operation, patient-reported

dysphagia, and cost. Overall, the panel felt that the effects

were of small size.

1. Patient reported symptom recurrence less than 2uni00A0years

(1 observational study of 249 participants) absolute dif-

ference 98 fewer patients per 1000 (95% CI 117 fewer

to 40 fewer) [63]

2. Perioperative complications (7 observational studies

with 1211 participants) absolute difference 16 fewer

patients per 1000 (95% CI 22 fewer to 1 more )[58, 60,

61, 63–69]

3. Reoperations (4 observational studies with 534 par-

ticipants) absolute difference 9 fewer patients per 1000

(95% CI 17 fewer to 18 more) [60, 61, 63, 65]

4. Patient reported dysphagia greater than 3uni00A0months (3

observational studies with 450 participants) absolute dif-

ference 77 fewer patients per 1000 (95% CI 154 fewer to

27 more) [61, 63, 65]

The Expert Panel noted that the evidence was based on

short term, observational studies. In addition, symptom

recurrence is not an objective outcome and may not accu-

rately reflect true reflux recurrence.

Harms anduni00A0burdens

There were five outcomes with undesirable effects for MSA

relative to Nissen fundoplication. The panel voted that the

magnitude of these effects was small.

1. Quality of life greater than 2uni00A0years (3 observational stud-

ies with 610 participants), Standardized Mean Differ-

ence (SMD) 0.14 pooled SD lower (95% CI 0.32 lower

to 0.04 higher) GERD-HRQL scale was used to measure

the quality of life in all of the studies [58, 59, 65]

2. Patient reported complete reflux symptom resolution

less than 2uni00A0years (2 observational studies with 118 par-

ticipants) absolute difference 40 fewer patients per 1000

(95% CI 173 fewer to 138 more) [61, 66]

3. Need for PPI (6 observational studies with 1445 partici-

pants) absolute difference 3 more patients per 1000 (95%

CI 49 fewer to 86 more) [59–61, 63–65]

4. Dysphagia requiring intervention (4 observational stud-

ies with 297 participants) absolute difference 56 more

per 1000 (95% CI 14 fewer to 186 more) [60, 61, 65, 66]

5. Patient satisfaction (5 observational studies with 846

participants) absolute difference 9 fewer patients per

1000 (95% CI 60 fewer to 43 more) [59, 61, 62, 64, 65]

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence was evaluated as very low based

on outcomes namely, symptom recurrence, complications,

reoperation, long-term dysphagia (patient-reported), cost,

QoL, symptom resolution, PPI use, dysphagia requiring

intervention, and patient satisfaction. These outcomes were

primarily limited by serious risk of bias and imprecision.

Decision criteria anduni00A0additional considerations

The preoperative workup for both procedures is the same

with two relative contraindications for MSA currently

including patients with BMI over 35uni00A0kg/m

2

and significantly

impaired esophageal motility. Patients with an allergy to

nickel and/or titanium are also contraindicated to receive

MSA. As there was some discrepancy in terms of patient-

reported dysphagia versus dysphagia requiring intervention

after MSA, patients with preoperative bloating may benefit

from preoperative counseling. In addition, the expert panel

felt that patients who have previously undergone a sleeve

gastrectomy and have symptomatic GERD and those who

require options other than fundoplication could possibly

benefit from MSA.

Performing both MSA and fundoplication require knowl-

edge and skills in foregut surgery. There is a nuanced learn-

ing curve in appropriately selecting the sizing for MSA

placement necessitating adequate training, however, the

procedure is less technically demanding than fundoplica-

tion. Despite being FDA approved for use, MSA has not

been uniformly adopted globally for use in part due to lower

rates of insurance authorization and possibly due to the

increased up-front costs for the device. Although cost was a

non-informative outcome, there were 2 observational stud-

ies with 1610 participants that looked at cost information.

Surgical Endoscopy

1 3

MSA demonstrated an absolute difference of $132 USD

lower (95% CI $2512.81 lower to $2248.81 higher) than

fundoplication [65, 67]. Furthermore, current literature is

lacking data comparing MSA to partial fundoplication.

Conclusion

The panel judged that the desirable and undesirable effects

were balanced and thus favored neither MSA nor Nissen fun-

doplication. The choice for either procedure should be made

on a patient specific basis and consider other factors such

as BMI and esophageal dysmotility, which are relative con-

traindications for MSA, and areas that are less well deline-

ated such as patient bloating pre-operatively. Both MSA and

fundoplication are successful at treating GERD symptoms.

2b. Should treatment with MSA versus medical treatment

(PPI) be used for patients with GERD?

Recommendation

The panel suggests that adult patients with GERD may ben-

efit from MSA over continued PPI use. (conditional recom-

mendation, moderate certainty evidence).

Summary ofuni00A0theuni00A0evidence

From 74 studies there was a single randomized control trial

that guided the panel for decision making [68]. This single

study included 158 patients that were followed for one year.

No observational studies met inclusion criteria. There was

not informative data for QoL, patient-reported symptom

recurrence, dysphagia, hiatal hernia recurrence, complica-

tions, mortality, re-operation rates, and cost.

Benefits ofuni00A0intervention

The panel deemed the desirable effects of MSA compared

to PPI to be large despite the small number of patients and

the single study evaluated.

1. Patient reported complete reflux symptom resolution less

than 2uni00A0years (1 RCT of 148 participants) absolute differ-

ence 795 more patients per 1000 (95% CI 393 to 1, 524

more)

2. Need for PPI (1 RCT of 134 participants) absolute

difference 910 fewer patients per 1000 (95% CI 960

fewer—770 fewer)

3. Patient satisfaction (1 RCT of 134 participants) absolute

difference 786 more patients per 1000 (95% CI 181 more

to 3,181 more)

4. Objective reflux recurrence at 6uni00A0months, measured by

average number of reflux events (1 RCT of 158 par-

ticipants) absolute difference 38 fewer patients per 1000

(95% CI 140 fewer to 131 more)

Harms anduni00A0burdens

No undesirable effects were available for this comparison.

Thus, the magnitude of effect is unknown.

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence was evaluated as moderate based

on the reported outcomes for decision making. These out-

comes were primarily limited by imprecision, however the

RCT had low risk of bias. (See evidence profile in the EtD

framework, Supplement 4).

Decision criteria anduni00A0additional considerations

Given that there were no undesirable effects available, it

is impossible to say whether the effects favor either MSA

or PPI. PPI use is a straightforward and simple treatment

with minimal side effects, however long-term use has been

associated with osteoporosis and increased risk of frac-

tures among other concerns [5] and thus in this patient

population surgical treatment may be warranted. As it is a

medical treatment it does not carry the same risk of surgi-

cal complications that can occur with MSA. As mentioned

in the previous question there is a learning curve for MSA

implementation and adequate training is necessary. MSA is

currently not recommended for patients with BMI > 35uni00A0kg/

m

2

and poor esophageal motility which are two subgroups

that could be further studied. One aspect that this RCT

did not address is the cost differential between these two

treatment modalities as the upfront costs of a surgical pro-

cedure are much greater than the costs for medical treat-

ment in the short-term, but over the course of a lifetime

of medical treatment these cost differentials are unknown.

Conclusion

MSA has improved outcomes over PPI therapy in the short

term however the negative effects and long-term data are

not available. While a single well performed RCT has pro-

vided the first degree of data there is still a large amount

unknown about this comparison.

2c. Should endoscopic treatment with TIF 2.0 versus

fundoplication be used for patients with GERD?

Surgical Endoscopy

1 3

Recommendation

The panel suggests that adult patients with GERD may

benefit from fundoplication over TIF 2.0. (Expert Opinion

recommendation; GRADE recommendation was unable to

be determined due to lack of evidence).

Summary ofuni00A0theuni00A0evidence

The systematic review revealed a single non-randomized

observational study comparing TIF 2.0 to fundoplication

[69]. Due to the small size of the study, the outcomes were

non-informative and, thus, an EtD was unable to be created.

Recommendations are based only on expert opinion. The

panel noted that this lack of evidence could be due to the

lack of worldwide adoption of the TIF 2.0 procedure.

Benefits ofuni00A0intervention

The potential benefits of endoscopic treatment with TIF 2.0

include the fact that TIF 2.0 is an endoscopic procedure that

can be performed without surgical incisions. In addition,

there is evidence of long-term durability with TIF 2.0 [70,

71]. Finally, TIF 2.0 can control regurgitation allowing for

withdrawal of PPI use.

Harms anduni00A0burdens

The harms and burdens associated with this procedure

include the fact that the outcomes of endoscopic therapy

using TIF 2.0 in patients with dysmotility disorders are

unknown. In addition, the insertion of TIF 2.0 may be dif-

ficult in patients with a small jaw opening and those who

have difficult neck hyperextension. The introduction of the

TIF 2.0 device has the potential risk of esophageal laceration

during the foreign body insertion [72]. Since TIF 2.0 only

has an endoscopic view, inaccurate anchoring of the system

to adjacent visceral structures may occur due to the lack of

extraluminal visualization. TIF 2.0 as a standalone procedure

is currently not recommended in patients with a hiatal hernia

of greater than 2uni00A0cm, thus limiting this as an option for many

patients with GERD. Finally, TIF 2.0 is an advanced endos-

copy procedure that requires specialized training.

Conclusion

The low level of worldwide adoption of endoscopic treatment

with TIF 2.0 is correlated with lack of sufficient comparative

trials. Training and guidance on the TIF 2.0 endoscopic pro-

cedure could foster its implementation and adoption globally.

2d. Should endoscopic treatment with TIF 2.0 versus

medical treatment (PPI) be used for patients with GERD?

Recommendation

The panel suggests that adult patients with GERD may

benefit from TIF 2.0 over continued PPI (conditional rec-

ommendation, moderate certainty of evidence).

Summary ofuni00A0theuni00A0evidence

Four RCTs were used to inform the panel’s decision making

that included 233 patients comparing TIF 2.0 and PPI [73–76].

Benefits ofuni00A0intervention

The panel deemed there to be moderate desirable effects

of TIF 2.0 compared to PPI.

? Short-term patient reported reflux symptom resolution

(3 RCTs of 216 participants) absolute difference 213

more patients per 1000 (95% CI 30 fewer to 595 more)

[73–75]

? Need of PPI (3 RCTs with 233 patients) absolute dif-

ference 696 fewer patients per 1000 (95% CI 820 fewer

to 448 fewer) [73–75]

? Patient satisfaction (1 RCT of 57 participants), 51.4%

of TIF 2.0 patients vs. 0% of PPI patients reported

being satisfied, thus an absolute effect was not estima-

ble [76]

? Objective reflux recurrence (1 RCT of 33 participants)

absolute difference 517 fewer patients per 1000 (95%

CI 591 to 215 fewer) [75]

? Quality of life less than 2uni00A0years (2 RCTs with 86 par-

ticipants) SMD ?0.5 (95% CI ?0.97 to ?0.03) [73, 75]

? Two QoL scales used: Quality of Life Reflux and Dys-

pepsia (QOLRAD) questionnaire and GERD Health

Related Quality of Life (GERD-HRQL) scale

Harms anduni00A0burdens

The expert panel deemed the undesirable effects of TIF 2.0

compared to PPI use to be small.

? Complications (2 RCTs with 173 total patients, how-

ever, only one study contributed to event data), abso-

lute effect 37 more patients per 1000 (95% CI 9 fewer

to 400 more) [73, 74].

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty evidence was evaluated as moderate based

on the reported outcomes for decision making. These

Surgical Endoscopy

1 3

outcomes were primarily limited by small sample size and

wide confidence intervals. (See evidence profile in the EtD

framework, Supplement 4).

Decision criteria anduni00A0additional considerations

foruni00A0KQ2c + d

In evaluating TIF 2.0 as an intervention there is a general

paucity of studies that met the inclusion criteria. This could

be attributed to the decreased adoption of TIF 2.0 worldwide

likely due to a combination of lack of training and insurance

coverage. However, there has been extensive use of this pro-

cedure in the USA. Implementation of this procedure does

require a highly skilled endoscopist and there is a learning

curve when adopting it as a new treatment similar to MSA,

although there is also a learning curve with the laparoscopic

fundoplication.

Relative contraindications for TIF 2.0 include the con-

current presence of obesity and severe esophagitis. Addi-

tionally, TIF 2.0 is contraindicated in patients with a hiatal

hernia greater than or equal to 2uni00A0cm. For this reason, some

surgeons and gastroenterologists advocate for a combined

TIF 2.0 and minimally in invasive hiatal hernia repair under

the same general anesthetic. These procedures are per-

formed sequentially, with the hiatal hernia repaired first and

the TIF performed after the intra-abdominal procedure has

concluded. The combination of these procedures turns TIF

2.0 from an incisionless procedure to an invasive abdominal

procedure. This combination of procedures is an evolving

technique, and comparative data was not available for the

current analysis.

Additional considerations include that TIF 2.0 is a stand-

alone procedure and is not universally covered by insurance

which has been an obstacle to adoption. When TIF fails and

repeat intervention is necessary, there is not a consensus

as to the best revisional approach. Some advocate for tra-

ditional full or partial fundoplication on top of an existing

TIF valve, while others advocate taking the TIF down first.

There are differences of opinion on the suitability and safety

of each of these approaches among experts.

Conclusion

TIF 2.0 is an intervention for those who want to avoid both

traditional surgery and lifelong medication. TIF 2.0 has the

advantage of being a potentially entirely endoscopic and

incisionless intervention. Given widely held opinions about

the side effects and risks of traditional fundoplication proce-

dures, additional long-term prospective comparative studies

of TIF (and especially combined laparoscopic hiatal hernia

repair and endoscopic TIF) versus fundoplication (partial

fundoplication in particular) are needed.

2e. Should endoscopic treatment with Stretta versus fun-

doplication be used for patients with GERD?

Recommendation

The panel suggests that adult patients with GERD may ben-

efit from fundoplication over Stretta. (conditional recom-

mendation, very low certainty of evidence).

Summary ofuni00A0theuni00A0evidence

Eight non-randomized comparative studies met inclusion

criteria and were used for the final recommendation [77–84].

There was no evidence regarding hiatal hernia recurrence or

perioperative mortality.

Benefits ofuni00A0Intervention

The panel deemed there to be small desirable effects of

Stretta compared to fundoplication.

? Perioperative complications (2 observational study with

283 participants) absolute difference 80 fewer patients

per 1000 (95% CI 125 fewer to 9 more) [77, 78]

? Dysphagia requiring intervention (2 observational study

with 279 participants) absolute difference 43 fewer

patients per 1000 (95% CI 49 fewer to 94 more) [79, 80]

? Cost—mean hospital costs (1 observational study with

140 participants) $1,808 USD after Stretta versus $5,715

USD after laparoscopic Nissen fundoplication [81]

Harms anduni00A0burdens

The panel deemed there to be moderate undesirable effects

of Stretta compared to fundoplication.

? Quality of Life—Short Term less than 2uni00A0years (1 obser-

vational study with 283 participants using the Quality of

Life in Reflux and Dyspepsia (QOLRAD) questionnaire)

mean difference 0.5 points lower with Stretta (95% CI 0.9

lower to 0.06 lower) [81]

? Objective Reflux Recurrence—Short Term less than

2uni00A0years (1 observational study with 226 participants

assessed with the mean DeMeester Score) mean differ-

ence 1.5 points higher with Stretta (95% CI 0.22 higher

to 2.78 higher) [78]

? Subjective Reflux Recurrence—Long Term greater than

2uni00A0years (1 observational study with 57 participants)

absolute difference 4 more patients per 1000 (95% CI 91

fewer to 387 more) [77]

Surgical Endoscopy

1 3

? Subjective Reflux Resolution—Long Term greater than

2uni00A0years (1 observational study with 57 participants) abso-

lute difference 123 fewer patients per 1000 (95% CI 250

fewer to 187 more) [77]

? Reoperation Required (2 observational studies with 191

participants) 15.4% (14/91 patients) after Stretta versus

0% (0/100) after fundoplication. Absolute difference not

estimable [82, 83]

? Need for PPI (3 observational studies with 345 partici-

pants) absolute difference 167 more patients per 1000

(95% CI 80 fewer to 905 more) [80, 83, 84]

? Patient Satisfaction (2 observational study with 123 par-

ticipants) absolute difference 179 more patients per 1000

(95% CI 312 fewer to 16 fewer) [77, 83]

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence was evaluated as very low based

on the reported outcomes for decision making. These out-

comes were primarily limited by small sample size and wide

confidence intervals that spanned several clinically meaning-

ful thresholds (Supplement 4).

2f. Should endoscopic treatment with stretta versus medi-

cal treatment (PPI) be used for patients with GERD?

Recommendation

The panel suggests that adult patients with GERD may ben-

efit from Stretta over PPI. (conditional recommendation, low

certainty of evidence).

Summary ofuni00A0theuni00A0evidence

A systematic review revealed five RCTs that met inclusion

criteria [85–89]. These trials did not report on subjective

reflux recurrence, dysphagia requiring intervention, hiatal

hernia recurrence, mortality, or cost.

Benefits ofuni00A0intervention

The panel deemed there to be moderate desirable effects of

Stretta compared to PPI.

? Quality of Life-Short Term less than 2uni00A0years (3 RCTs with

89 participants assessed with the 36-Item Short Form

Health Survey (SF-36) and the GERD-Health-Related

Quality of Life (GERD-HRQL) survey) standardized

mean difference 1.6 SD higher with Stretta (95% CI 1.12

higher to 2.1 higher) [85–87]

? Subjective reflux symptom resolution-short Term less

than 2uni00A0years (3 RCTs with 122 participants) absolute

difference 58 more patients per 1000 (95% CI 133 fewer

to 1008 more) [86–88]

? Need for PPI (4 RCTs with 143 participants) absolute

difference 144 fewer patients per 1000 (95% CI 297 fewer

to 38 more) [86–89]

? Patient satisfaction (1 RCT with 20 participants) absolute

difference 501 more patients per 1000 (95% CI 6 fewer

to 1866 more) [89]

Harms anduni00A0burdens

The panel deemed there to be small undesirable effects of

Stretta compared to PPI.

? Perioperative complications (2 RCTs with 86 partici-

pants) absolute difference 50 more patients per 1000

(95% CI 10 fewer to 417 more) [86, 88]

? Dysphagia-patient reported (1 RCT with 24 participants)

1/12 (8.3%) reported dysphagia after Stretta and zero

patients had dysphagia with PPI use. Absolute difference

was not estimable [86]

? Required additional procedures (1 RCT with 62 partici-

pants) absolute difference 253 more patients per 1000

(95% CI 17 more to 582 more), many of these procedures

were an additional treatment with Stretta. [88]

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence was evaluated as low based on

the reported outcomes for decision making. Although data

originated from RCTs, these studies were primarily limited

by small sample sizes, resulting in wide confidence intervals

that spanned several clinically meaningful thresholds. (See

evidence profile in the EtD framework, Supplement 4).

Decision criteria anduni00A0additional considerations

foruni00A0KQ2e + f

During fundoplication surgeons can concurrently repair

a concomitant hiatal hernia, as such Stretta has limited

applicability in these patients. There is significantly more

long-term data available for fundoplication than there is for

Stretta. In addition, Stretta is ineffective in patients with very

low lower esophageal sphincter pressure (LES) [78]. There

could be a possible placebo effect with Stretta that should be

considered due to the lack of physiologic difference change

to lower esophageal with Stretta. In the systematic review,

there was insufficient data for objective reflux control after

Stretta.

The potential benefits of endoscopic treatment with

Stretta include the fact that Stretta does not require gen-

eral anesthesia since it is performed using a standard EGD,

Surgical Endoscopy

1 3

thus should be considered in patients who are otherwise at

high risk for surgery or those patients that wish to avoid

surgery. In addition, Stretta is easier and a more consist-

ently reproducible procedure than fundoplication with

a considerably lower learning curve. Compared to fun-

doplication, Stretta does not affect surgical anatomy and

it may be easier to perform another subsequent procedure

if it fails. Furthermore, Stretta is a reasonable option for

patients with severe reflux, who may not be candidates for

fundoplication, such as post-sleeve gastrectomy. Although

the technology associated with Stretta may not be avail-

able everywhere, its global adoption makes it feasible to

implement in high-, middle-, and low-income countries.

Conclusion foruni00A0KQ2e + f

Stretta is a still evolving technology that has not been widely

adopted. Increased training and proctoring in the technique

are needed world-wide before the technology will improve.

Research recommendations foruni00A0KQ2a-f

There are a number of future research recommendations that

the panel felt were needed. Comparative trials (randomized

controlled trials where practical and feasible) may be of

benefit in strengthening several of these recommendations.

Outcomes should be objective, standardized where feasible,

and patient centered.uni00A0There should also be standardization

of all the procedures to more reliably be able to compare the

different techniques and studies from other institutions. All

included studies in KQ2a compared MSA to Nissen fun-

doplication. To our knowledge, there is no high-level data

that compares MSA to partial fundoplication and this is a

potential area for future research. More long-term, durabil-

ity studies would also contribute to our understanding of the

pros and cons of the different GERD interventions. Finally,

the panel felt that examining the strategy currently advocated

by some surgeons and endoscopists of Concomitant Laparo-

scopic Hiatal Hernia Repair + endoscopic TIF (c-TIF) should

be a research priority. In 2017 the FDA expanded the use of

TIF to patients with a hiatal hernia greater than 2uni00A0cm when

performed in combination with a hiatal hernia repair. This

allows its use in a broader patient population. This approach

was not compared in this guideline.

(KQ3) Should partial oruni00A0complete

fundoplication be used inuni00A0adult patients

withuni00A0GERD?

3a. Should partial fundoplication versus complete fundopli-

cation be used in adults with GERD?

Recommendation

The panel suggests that adult patients with GERD may

benefit from partial fundoplication compared to complete

fundoplication. (conditional recommendation, moderate

certainty of evidence).

Summary ofuni00A0theuni00A0evidence

From 70 studies there were 20 RCTs (39 individual stud-

ies)[7, 90–112] and 31 observational studies that met inclu-

sion criteria [113–143]. In order to avoid double counting

patients in follow-up studies from the same initial trial

enrollment, RCTs and their follow-up reports were reviewed

and outcomes with the longest follow up or largest sample

size were chosen for inclusion in the analysis.

Benefits ofuni00A0theuni00A0intervention

There were three outcomes with desirable effects for partial

as compared to complete fundoplication. Overall, the panel

felt that the effects were moderate.

1. Hiatal Hernia Recurrence (8 RCTs with 832 partici-

pants), absolute effect 30 fewer patients per 1000 (95%

CI 43 fewer to 5 fewer) [90–97]

2. Postoperative dysphagia, requiring intervention (11

RCTs with 1,045 participants), absolute effect 47 fewer

patients per 1000 (95% CI 58 fewer to 24 fewer) [91, 93,

98–106]

3. Gas/bloat/inability to vomit greater than 1uni00A0year (10

RCTs with 860 participants), absolute effect 115 fewer

patients per 1000 (95% CI 186 fewer to 18 fewer) [7, 90,

93, 96, 98, 99, 106–108, 112]

Gathered data did not include how recurrence or hiatal

hernia was measured or stratified based on symptomatol-

ogy, with extraction criteria being recurrence > 3uni00A0cm and/or

symptomatic recurrence. These factors may have introduced

some variability into the data.

Harms anduni00A0burdens

There were two outcomes with undesirable effects for par-

tial fundoplication relative to complete. The panel voted the

magnitude of these effects to be small.

1. Complete subjective reflux symptom resolution greater

than 1uni00A0year (14 RCTs with 1289 participants), absolute

effect 16 fewer patients per 1000 (95% CI 48 fewer to

24 more) [90, 93, 94, 97, 102–104, 106–112]. Follow-up

in these studies ranged from 1y-20y with 7 of 14 trials

having > 5y follow-up

Surgical Endoscopy

1 3

2. Objective reflux recurrence greater than 1uni00A0year (6 RCTs

with 851 participants) absolute effect 45 more patients

per 1000 (95% CI 14 fewer to 143 more) [96, 98, 101,

103, 111, 112]

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of data for these effects was deemed moderate.

(See evidence profile in the EtD framework, Supplement 5).

Decision criteria anduni00A0additional considerations

The consensus is based on the demonstrated decreased post-

operative side effects after partial fundoplication compared

to the limited differences in long-term reflux control, both

of which are supported with moderate strength evidence.

Although there were several RCTs contributing evidence

to this recommendation, many of the participating surgeons

in these studies practiced at academic, tertiary care centers,

which may limit the generalizability to the average general

surgeon and potentially introduce surgeon bias. Furthermore,

the pooled studies included several different types of partial

fundoplications, which adds some heterogeneity to the popu-

lation included, however, this did not appear to translate into

any heterogeneity within the outcomes. Nevertheless, for

all outcomes, the observational studies included in the sys-

tematic review supported the RCT findings. There are many

caveats not accounted for in this data, many of which are

related to the preoperative evaluation of the patient which

can be highly variable. Many patients’ primary complaint

is related to heartburn and as such the goal is to treat this

symptom. This is balanced with patients’ desire to avoid dys-

phagia and other side effects associated with a complete fun-

doplication, including long-term gas bloat symptoms. These

patients may be more satisfied with a partial fundoplication.

Areas of special consideration include patients with

objective findings of severe GERD (such as Barrett’s esoph-

agus, dysplasia, or severe esophagitis) or those who are post

lung transplantation who may value objective GERD resolu-

tion in order to prevent progression of their esophageal or

lung disease (e.g., graft failure) over fear of postoperative

dysphagia, gas bloat, and inability to vomit.

Conclusion anduni00A0research recommendations

Future research recommendations should focus on improved

long-term data with larger sample sizes to better elucidate

the treatment effect. In addition, studies should be performed

to determine patients’ values on outcomes for their treat-

ment of GERD, such as the importance of symptoms and

QoL measures. There should also be studies in which there

is standardization of procedures (i.e., reviewing videos of

techniques) as well as competence-based assessments for

training in order to compare procedures adequately. Finally,

studies that compare the different partial fundoplication

techniques are needed. Significant education to surgeons will

also have to be provided to change longstanding practice of

some who only perform complete fundoplication.

3b. Should complete fundoplication versus partial fun-

doplication be used for adult patients with GERD who have

esophageal dysmotility on preoperative manometry?

Recommendation

The panel suggests that adult patients with GERD and pre-

operative dysmotility may benefit from partial over complete

fundoplication. (conditional recommendation, low certainty

of evidence).

Summary ofuni00A0theuni00A0evidence

From 7 studies there were 3 RCTs [95, 103, 104, 110] and 4

observational studies that met inclusion criteria [115, 117,

118, 144].

Benefits ofuni00A0theuni00A0intervention

There were two outcomes with desirable effects for partial

as compared to complete fundoplication in patients with pre-

operative dysmotility. Overall, the panel felt that the effects

were moderate.

1. Complete subjective reflux symptom resolution greater

than 1uni00A0year (1 RCT with 100 participants), absolute

effect 61 more patients per 1000 (95% CI 91 fewer to

243 more) [103]

2. Postoperative dysphagia, patient reported (3 RCTs with

173 participants), absolute effect 144 fewer patients per

1000 (95% CI 215 fewer to 21 fewer) [95, 103, 104, 110]

Although there is some clinical benefit, the CI of com-

plete reflux symptom resolution ranges from small benefits

to small harms, thus there was no significant difference

between the partial and complete fundoplication.

Harms anduni00A0burdens

There was one outcome with undesirable effects for partial

fundoplication relative to complete. The panel voted the

magnitude of these effects to be trivial.

1. Objective reflux recurrence greater than 1uni00A0year, assessed

by median postoperative DeMeester Score (1 observa-

tional study with 51 participants) mean difference 5

points higher 95% CI 22.59 lower to 32.59 higher) [144]

Surgical Endoscopy

1 3

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The overall certainty of evidence is low (See evidence profile

in the EtD framework, Supplement 5).

Decision criteria anduni00A0additional considerations

When using their collective patient experience to con-

sider patient values, the panel surmised there are groups of

patients who may prefer reflux control over worsening dys-

phagia, including those who had a lung transplant or those

with scleroderma. There are also a few other caveats when

considering implementing this guideline into clinical prac-

tice related to the definition and the cause of the pre-opera-

tive dysphagia. There are patients in whom dysmotility may

be due to the degree of esophagitis and not an underlying

functional disorder. There are also patients with manometric

findings of esophageal dysmotility who may or may not have

symptoms of dysphagia [145]. There is no standard defini-

tion of dysmotility used in the referenced studies and there-

fore when comparing multiple studies, it is difficult to know

if all patients have similar abnormal degrees of motility.

Conclusion anduni00A0Research Recommendations

Developing a better correlation between dysmotility and

dysphagia which would allow for a better understanding

of the impact of a complete and partial fundoplication on

esophageal motility and is an important future research rec-

ommendation. Further future research priorities include the

acquisition of better long-term data with larger sample sizes

and of data comparing patient symptoms and QoL measures.

Again, there is a lack of standard definitions and compari-

son of types of partial fundoplication. Comparison between

anterior versus posterior and degree of partial fundoplication

would clarify what partial fundoplication can and should be

recommended in patients who would benefit from a partial

wrap.

(KQ4) What is the best treatment for adult patients with

obesity (BMI uni2265 35) and concomitant GERD?

4a. Should candidate patients with obesity (BMI uni2265 35)

and GERD undergo RYGB versus LNF for optimal control

of their GERD?

Recommendation

The panel suggests that patients with medically refractory

GERD and a BMI uni2265 35 may benefit from either RYGB or

fundoplication. (conditional recommendation, very low cer-

tainty of evidence).

Summary ofuni00A0evidence

There were two observational, comparative studies that met

inclusion criteria [146, 147]. Data from these two studies

were used in the creation of our EtD and, subsequently, final

recommendations. There was a mean BMI of 46.2uni00A0kg/m

2

in

the patients who underwent RYGB and 34.7uni00A0kg/m

2

in those

who underwent fundoplication. Additionally, there were sev-

eral single-arm case series that observed outcomes in either

fundoplication or RYGB for GERD in patients with obesity

that were not evaluated in the comparative studies included

in our EtD.

The findings of these single arm studies are summarized

here. Reported rates of 30-day mortality between the two

groups were quite similar, however, this data is further

limited by the small event rate [148–157]. There were also

similar rates of reoperation; four studies which averaged a

1.93% (range 1.22–3.05%) reoperation rate for fundoplica-

tion [149, 150, 158, 159] compared to a rate of 2.54% (range

2.02–3.2%) for the RYGB group [152–154, 157]. There were

three studies which averaged a 1.4% (range 0.41–4.73%)

hiatal hernia recurrence after fundoplication [148, 158, 159].

However, there were two studies which evaluated hiatal

recurrence after RYGB reporting a rate of 43.27% (range

32.48–54.75%) [155, 160]. Overall, these studies had small

sample sizes and were composed of heterogeneous popula-

tions, therefore no direct comparisons can be made.

Of note, these studies only addressed the question of

change in GERD symptoms after the interventions in

patients with obesity and no additional aspects of weight

loss or other co-morbid conditions were considered.

Benefits ofuni00A0theuni00A0intervention

There was one outcome in the EtD with desirable effects

for RYGB as compared to fundoplication in patients with

obesity. Overall, the panel felt that the effects were small.

1. Complete subjective reflux symptom resolution less than

2uni00A0year (1 observational study with 100 participants),

absolute effect 136 more patients per 1000 (95% CI 25

more to 254 more) [146]

Harms anduni00A0burdens

There were two outcomes with undesirable effects for RYGB

as compared to fundoplication in patients with obesity. Over-

all, the panel felt that the effects were moderate.

1. Objective reflux recurrence greater than 1uni00A0year, assessed

by mean postoperative DeMeester Score (1 observa-

tional study with 12 participants) mean difference 2.9

points higher (95% CI 1.6 higher to 4.3 higher) [147]

Surgical Endoscopy

1 3

2. Postoperative complications (2 observational study

with 112 participants), RYGB had a complication rate

of 7.4% versus 0% with fundoplication. Because there

were no events in the fundoplication arm, the absolute

effects are not estimable [146, 147]

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence of both desirable effects and

patient harm was very low (See evidence profile in the EtD

framework, Supplement 6).

Decision criteria anduni00A0additional considerations

Patient-reported GERD symptoms improved significantly

after RYGB; however, these findings were not consistent

with objective studies of GERD after these procedures

which favored fundoplication. There were fewer complica-

tions after fundoplication as compared to RYGB.

These studies were uniformly observational with sig-

nificant baseline differences (e.g., preoperative BMI and

DeMeester scores) that could have impacted the study

results. Studies did not evaluate objective findings such as

pre- and post-operative antacids therapy. Results for compli-

cations were based on only two events in the RYGB group.

The panel recognized that because this guideline was

focused on the treatment of GERD, there are many potential

additional and relevant benefits with RYGB, such as weight

loss and resolution of obesity-associated comorbidities. Of

note, patients included in these studies had a mean BMI

of 46.2uni00A0kg/m

2

in the RYGB group and 34.7uni00A0kg/m

2

in those

that underwent fundoplication. Patients with a higher BMI

may require additional multidisciplinary counseling before

a surgical decision is made.

Bariatric consultation should be strongly considered in

patients with morbid obesity for the treatment of associ-

ated metabolic comorbidities, not only GERD, before pro-

ceeding directly with fundoplication. However, there are

many patients in this category who are suffering with both

GERD symptoms and obesity complications and are will-

ing to consider fundoplication, but not bariatric surgery.

Insurance approval for bariatric procedures is also a big

hurdle and thus important to maintain that either approach

is acceptable.

It has been appreciated for many years that risk of reflux

recurrence after fundoplication is increased in patients with

morbid obesity [41, 161, 162], though there is contrary evi-

dence [148, 163]. It is postulated that higher postoperative

intraabdominal pressures can cause failure of the repair

[164]. Based on this knowledge, it has been suggested that

fundoplication may not be the preferred anti-reflux opera-

tion in the morbidly obese, and alternatives such as Roux-

en-Y gastric bypass (RYGB) may be superior. Systematic

review of comparative studies, as conducted above, do not

yet support this view. Though subjectively results may be

better, RYGB is a more complex operation, with two anas-

tomoses and significant alteration to anatomy, and not unex-

pectedly perioperative morbidity is increased. Moreover,

this increased risk in complication rate is not necessarily

achieved with superior objective control of reflux disease.

Numbers reviewed in our study are small, and there was a

low certainty of evidence.

Conclusion anduni00A0research needs

To date, no RCTs have been done comparing RYGB and

fundoplication in patients with obesity and GERD. These

studies could bring the much-needed certainty of evidence

to this clinical question, especially if long-term follow-up

is conducted. The feasibility of such a trial may present

an obstacle. Furthermore, studies evaluating outcomes of

patients with severe obesity may demonstrate more clarity

for this surgical question. Current literature does not address

outcomes after RYGB in patients who have pre-existing

motility disorders and/or atypical GERD symptoms. High-

quality comparative studies and RCTs addressing this patient

population would be beneficial. As endoluminal treatments

of GERD evolve, studies investigating their efficacy in

patients with obesity is also a matter of importance.

4b. Should adult, candidate patients with obesity

(BMI uni2265 35) and refractory GERD to best medical manage-

ment undergo sleeve gastrectomy versus LNF?

Recommendation

While sleeve gastrectomy is the most commonly performed

surgical procedure to treat obesity, it can be a refluxogenic

operation. As such, the expert opinion of the consensus rec-

ommends that a sleeve gastrectomy should not be performed

as an anti-reflux procedure (Expert Opinion, GRADE rec-

ommendation was unable to be determined due to lack of

evidence).

Summary ofuni00A0theuni00A0evidence

After systematic review of the literature, there were no com-

parative studies that evaluated the efficacy of fundoplica-

tion versus sleeve gastrectomy for the treatment of refractory

GERD in morbidly obese patients. As such, single arm stud-

ies were reviewed, and data extracted for either the interven-

tion or the comparator. Overall, these studies had very small

sample sizes and were composed of heterogeneous popula-

tions and thus no direct comparisons can be made.

In two studies, the rate of symptom resolution in obese

patients with GERD after fundoplication was 87.5% (range

81.4–97.8%) [148, 158]. There were nine studies which

Surgical Endoscopy

1 3

averaged a symptom resolution rate of only 22.1% (range

7.0–51.8%) after sleeve gastrectomy [165–173]. There were

similar rates of 30-day mortality between the two groups

[148–150, 167–169, 172]. In four studies, fundoplication

had a re-operative rate of 1.9% (range 1.2–3.1%) [149, 150,

158, 159]. Across nine studies, sleeve gastrectomy had a

re-operative rate of 9.2% (range 4.1–19.8%) [171, 172, 174,

175]. Fundoplication had a hiatal hernia recurrence of 1.4%

(range 0.4–4.7%) over three studies [148, 158, 159]. There

was only one study that looked at hiatal hernia recurrence

after sleeve gastrectomy (2.8%, range 1.1–7.3%) [168].

There was one study that showed 1.4% of obese patients

required anti-reflux medication (ARM) after fundoplication

[148]. There were five studies that reported an average of

26.4% (range 15.3%-41.6%) of patients required ARM after

sleeve gastrectomy [165, 167, 171, 173, 175–177].

Two studies of obese patients after fundoplication showed

that 7.0% (range 1.8–24%) of patients had dysphagia that

required intervention [149, 158]. In contrast, in two stud-

ies after sleeve gastrectomy, only 1.4% (range 0.7–2.9%)

of patients had dysphagia that required intervention [167,

168]. There were several outcomes for which only data on

sleeve gastrectomy was available. Over five studies, there

was an objectively established reflux recurrence in 43.7%

(range 25.1–64.2%) after sleeve gastrectomy [169–172,

177]. Lastly, in two studies, 1.4% (range 0.02–52.8%) of

patients were found to have Barrett’s esophagus after sleeve

gastrectomy [168, 169].

Decision criteria anduni00A0additional considerations

Given the absence of studies directly comparing fundopli-

cation to sleeve gastrectomy for the treatment of medically

refractory reflux in patients with morbid obesity, the recom-

mendations were made based on single-arms studies and

consensus of the expert panel. The limited literature avail-

able also did not delineate between worsening of preopera-

tive GERD or de novo GERD. Studies that demonstrated

de novo GERD were not included in the systematic review

since they did meet the inclusion criteria. With the current

evidence and preoperative workup, there is no process to

predict pre-operatively which patients without GERD will

develop GERD post-sleeve gastrectomy, especially given the

wide spectrum of practice in performing sleeve gastrectomy

(pre-op workup, bougie size, distance from pylorus, explora-

tion, and repair of concomitant hiatal hernias, etc.). While it

is appreciated that sleeve gastrectomy has a variable and not

easily predicted effect on reflux [178], sometimes worsening

it [179, 180] and sometimes improving reflux [181], this is

usually seen when performing the operation for the treat-

ment of obesity. Because of the uncertainty, the panelists

would always caution again sleeve gastrectomy in patients

with severe reflux and would never recommend sleeve

gastrectomy as a primary anti-reflux operation. Patients

with preoperative dysmotility, regurgitation, high-grade

esophagitis, and/or Barrett’s esophagus should be counseled

against sleeve gastrectomy due to the possibility of worsen-

ing GERD.

Conclusion anduni00A0research needs

The use of sleeve gastrectomy for the primary treatment of

GERD in the obese patient was not recommended by our

expert panel. While there is a lack of comparative studies

looking at outcomes for patients with morbid obesity and

GERD undergoing sleeve gastrectomy or fundoplication,

this dearth of data may be due to the current available data

suggesting that sleeve gastrectomy is a refluxogenic opera-

tion and that better primary ARS options such as LNF or

RYGB are available to treat patients with both obesity and

medically refractory GERD. In other words, sleeve gastrec-

tomy is a bariatric surgical procedure which may have ben-

eficial effects on GERD, but sleeve gastrectomy is never to

be considered a primary anti-reflux operation with beneficial

effects on weight.

Opportunities for research specific to this popula-

tion include outcomes for patients with hiatal hernia who

undergo sleeve gastrectomy, information regarding LES

integrity versus postoperative outcomes after sleeve gas-

trectomy, and the diameter of the sleeve affecting reflux

outcomes and de novo GERD.

4c. After failed fundoplication should RYGB versus a

redo fundoplication be performed for symptom control

in adult candidate patients with GERD and concomitant

obesity?

Recommendation

The panel suggests that adult patients with obesity and medi-

cally refractory GERD, who have failed previous fundopli-

cation, may benefit from either RYGB or redo fundoplication

based on surgeon and patient shared decision making. (con-

ditional recommendation, very low certainty of evidence).

Summary ofuni00A0evidence

No large, RCTs were available for inclusion. Limited data

was captured comparing redo fundoplication to RYGB in

patients with a BMI uni2265 35, as such, the panel decided to

increase the screening criteria to include patients with a

BMI uni2265 30. Data from five observational, comparative studies

from the systematic review were deemed critical or impor-

tant for clinical decision making and thus were included in

the EtD and informed decision making [182–186]. Across

these studies, there was a mean BMI of 33.2uni00A0kg/m

2

in the

patients who underwent RYGB and a mean BMI of 28.7uni00A0kg/

Surgical Endoscopy

1 3

m

2

in those that underwent fundoplication. As the data from

comparative studies was somewhat limited in this group of

patients, we elected to review single arm series for both

the comparator and intervention for this KQ. All patients

included in the study by Antiporda etuni00A0al. [182] had under-

gone uni2265 1 prior repeat fundoplication before either undergo-

ing another fundoplication or RYGB. In the other included

studies, majority of patients had only had the original fun-

doplication before study inclusion, however, a small propor-

tion of patients had received multiple fundoplications before

study inclusion. The study by Shao etuni00A0al.[184] did not report

on how many prior fundoplications patients received. Across

the 4 studies reporting number of prior fundoplications, the

Redo Fundoplication groups had a mean of 1.4 prior fun-

doplications and the RYGB groups had a mean of 1.9 prior

fundoplications.

There were two outcomes where comparative data was

lacking, objective reflux recurrence and progression to Bar-

rett’s esophagus. There was one single arm study which

reported a 10.1% (range 5.2–19.0%) rate of objective reflux

recurrence after RYGB in patients with obesity who had

previously failed fundoplication [187]. Even in our query of

single arm studies, there were no reports of progression to

Barrett’s esophagus in either redo fundoplication or RYGB

after failed fundoplication.

Benefits ofuni00A0theuni00A0Intervention

There were three outcomes with desirable effects for RYGB

as compared to fundoplication in patients with obesity. Over-

all, the panel felt that the effects were small.

1. Complete subjective reflux symptom resolution less than

2uni00A0year (4 observational studies with 483 participants),

absolute effect 0 more/fewer patients per 1000 (95% CI

65 fewer to 65 more) [182–185]

2. Hiatal hernia recurrence (1 observational study with 63

participants), absolute effect 43 fewer patients per 1000

(95% CI 110 fewer to 464 more) [182]

3. Need for ARM (1 observational study with 152 partici-

pants), absolute effect 15 fewer patients per 1,000 (95%

CI 105 fewer to 184 more) [183]

The confidence interval for subjective reflux symptom

resolution is compatible with clinically relevant, albeit

small, benefits to clinically relevant, albeit small, harms for

patient symptom resolution.

Harms anduni00A0burdens

There were four outcomes with undesirable effects for

RYGB as compared to fundoplication in patients with obe-

sity. Overall, the panel felt that the effects were moderate.

1. Patient reported symptom recurrence greater than 2uni00A0year

(1 observational study with 180 participants) absolute

effect 42 more patients per 1000 (95% CI 46 fewer to

220 more) [184]

2. Perioperative complications (4 observational studies

with 515 participants) absolute effect 52 more patients

per 1000 (95% CI 13 fewer to 155 more) [182–185]

3. Perioperative mortality (5 observational studies, how-

ever only one contributed event data, with 698 total

patients); RYGB had one death (0.4%) across all stud-

ies, whereas redo fundoplication had no postoperative

mortality (0%) [182–186]

4. Reoperation (3 observational studies with 363 partic-

ipants) absolute effect 96 more per 1000 (95% CI 19

more to 330 more) [182, 184, 185]

There were two observational studies which looked at

dysphagia requiring intervention after either RYGB or

redo fundoplication, however they observed vastly differ-

ent findings. Weber etuni00A0al. reported lower rates of dysphagia

after redo fundoplication (6%) compared to RYGB (44.4%)

[185]. However, Yamamoto etuni00A0al. reported dysphagia rates

of 18.5% after redo fundoplication compared to 0% after

RYGB [186]. The reviewers could not discern meaning-

ful differences in population, follow-up, or interventions to

explain these differences, thus this outcome was excluded

from decision making.

Certainty inuni00A0theuni00A0evidence ofuni00A0effects

The certainty of evidence was deemed to be very low based

on the outcomes determined to be critical or important to

decision making by the expert panel: patient-reported symp-

tom improvement (critical), patient-reported symptom recur-

rence (critical), perioperative complications (important),

perioperative mortality (important), and need for reoperation

(important). The outcomes were primarily limited by unclear

risks of bias and wide CI which increase the imprecision

of the results. (See evidence profile in the EtD framework,

Supplement 6).

Decision criteria anduni00A0additional considerations

Due to the important variability in patient values, particu-

larly the value of weight loss versus GERD resolution, the

panelists felt that despite the balance of effects, that either

RYGB or redo fundoplication may be chosen for patients

with both GERD and obesity.

Experienced surgeons understand that revisional foregut

surgery may be significantly more challenging than the pri-

mary operation[161], and the greater the tools available to

the surgeon, the greater the chance for success. The anatomic

derangements incurred in prior surgery, with interruptions

Surgical Endoscopy

1 3

to vascularity, perhaps a non-viable fundus, alterations in

hiatal anatomy and other changes may prevent re-fundopli-

cation no matter the initial intent of the operating surgeon.

It is of expert opinion that in patients who have previously

undergone multiple revisions, more consideration should be

given to conversion to a RYGB. In addition, this recom-

mendation does not address the difference in outcomes in

patients with obesity and a lower BMI to patients with a

higher BMI. Patients with higher BMI and GERD should

be strongly advised to undergo a RYGB since articles that

evaluate anatomical findings in revisional procedures after

failed fundoplication reported partially herniated, herniated,

or slipped wraps [188]. The BMI threshold for this recom-

mendation was not established by the expert panel. The evi-

dence regarding delayed gastric emptying in these groups

was not reviewed, however, it is of expert opinion that in

patients with delayed gastric emptying, conversion to gastric

bypass should be given more consideration.

Conclusion anduni00A0research recommendations

The expert panel recommends that a large, RCT of revisional

fundoplication versus conversion to RYGB would provide

valuable insight. The feasibility of conducting such a trial

is a likely obstacle. At minimum, a well-designed matched

comparative study would improve the grade of evidence,

especially those that evaluate patients with more severe obe-

sity (BMI uni2265 35). The panel recommends including preopera-

tive esophageal and gastric motility studies as well as gastric

emptying studies after interventions for failed fundoplica-

tion. Finally, patients who have undergone multiple revisions

should be a focus of future research.

Discussion

What isuni00A0new inuni00A0this guideline?

SAGES published a guideline in 2021 discussing the sur-

gical treatment of GERD, which covered differing aspects

than this current guideline [189]. The main difference in this

guideline is the presence of multiple representatives from

various societies bringing together different expertise to fur-

ther enrich, engage, and drive the consensus discussions.

Additionally, this guideline focuses on pre-operative testing,

endoscopic approaches, and GERD associated with obesity,

which the earlier guideline did not address.

Implementation

The consensus believes that it is feasible to successfully

implement these recommendations into local practice and

that the recommendations will be accepted by stakeholders.

The main considerations regarding implementation of this

guideline include costs and availability of the testing and

treatment options. In addition, some of the recommended

techniques require specialized knowledge and skills. Finally,

to achieve the full benefit of these recommendations, stand-

ardizing aspects of GERD treatment is required, including

LA grading, esophagograms, manometry, and the technical

components of the fundoplication. The panel plans to survey

physicians in the future to monitor and audit compliance

with the recommendations put forth in this guideline.

Updating this guideline

SAGES plans to repeat a comprehensive literature review in

three years to reevaluate and identify new evidence. Particu-

lar attention will be paid to any future studies that specifi-

cally address the research recommendations proposed in this

guideline. A formal update will be generated when substan-

tial literature is detected. The adoption and implementation

of this guideline’s recommendations will be assessed at an

interval time in the future.

Limitations ofuni00A0this guideline

One of the main limitations of this guideline is the low cer-

tainty of evidence for most of the KQ, except for KQ 3. In

addition, patient’s values and preferences were not actually

obtained and instead the panel’s impression of their beliefs

was used based on experiences with patients. While the

recommendations in this guideline are based on the high-

est-level evidence meeting inclusion criteria, there may be

certain areas globally with limited access to certain test-

ing, such as pH-testing and HREM, as well as individual

procedures or technologies. Insurance coverage and cost

to society was not addressed in this guideline as it took a

patient-centered perspective. In the development of the rec-

ommendations, we were not able to consider certain aspects

of diversity, equity, and inclusion due to unavailability in the

literature that was reviewed, thus may limit their generaliz-

ability. Specifically, various populations might have been

underrepresented in the studies that were evaluated such as

ethnic minorities or patients in lower socioeconomic areas.

Additional research should be devoted to addressing these

issues and as well as the effects of access to care as it relates

to the treatment of GERD.

Conclusion

Through the development of these evidence-based recom-

mendations, the consensus conference proposed a treatment

algorithm for aid in the treatment of GERD (Fig.uni00A01). Patients

with typical symptoms should undergo EGD, manometry,

and pH-testing; additional testing may be required for

Surgical Endoscopy

1 3

patients with atypical symptoms. MSA or fundoplication are

both acceptable. MSA has better outcomes than PPI alone.

Patients with normal or abnormal findings on manometry

should undergo partial fundoplication. For patients that

wish to avoid surgery, Stretta and TIF 2.0 were found to

have better outcomes than PPI alone. Patients with concomi-

tant obesity were recommended to undergo either RYGB

or fundoplication, although patients with BMI > 50 should

undergo RYGB for the additional benefits that follow weight

loss and comorbidities resolution.

Using the recommendations and algorithm developed

by this panel, physicians may better counsel their patients

with GERD. Engaging in the identified research areas may

improve future care for GERD patients.

Disclaimer

Clinical practice guidelines are intended to indicate the best

available approach to medical conditions as established by

a systematic review of available data and expert opinion.

The approach suggested may not necessarily be the only

acceptable approach given the complexity of the healthcare

environment. This guideline is intended to be flexible, as the

surgeon must always choose the approach best suited to the

patient and to the variables at the moment of decision. This

guideline is applicable to all physicians who are appropri-

ately credentialed regardless of specialty and address the

clinical situation in question. Some studies or treatment

options may not be available in certain regions, and as such

individual decision making must be used.

This guideline is developed under the auspices of SAGES,

the guidelines committee, and approved by the Board of

Governors. The recommendations of each guideline undergo

multidisciplinary review and are considered valid at the time

of production based on the data available.

Supplementary Information The online version contains supplemen-

tary material available at https:// doi. org/ 10. 1007/ s00464- 022- 09817-3.

Acknowledgements We would like to thank Jillian Kelly, the SAGES

senior program coordinator, Holly Burt, the SAGES librarian, and the

SAGES guideline committee members for their help with the creation

of this guideline.

Funding There was no funding for this manuscript.

Declarations

Disclosure BS—Consultant for Hologic and Cook Medical, AC, APQ,

MRR, SK, EC, SW, AAS, MTA, DIA, SD, FD, JH, KK, AL, MD,

VL, DL, AP,CW,GPK, RV, AT—no conflicts of interest, RD—Per-

sonal stock in Johnson and Johnson, JCG—Preceptor for Ethicon/J + J,

Fig. 1 Treatment Algorithm for adult patients with gastroesophageal reflux disease (GERD)

Surgical Endoscopy

1 3

Speaker for BD, RJ—Speaker for Medtronic, Intuitive Surgical, and

Aspire Medical, Consultant for Intuitive Surgical, Expert Review for

BSPH Law, INH—Royalty for uptoDate. ISS—Proctor for Intuitive

Surgical, NT—Consultant for Boston Scientific Corp, Pentax America,

Ambu, Biotex Inc, Speaker for Abbvie, Royalty for UpToDate, Crea-

torship Rights for ROSEAID inc, VV—Advisory board and speaker

for Integra Biosciences, Consultant for Innocoll Pharmaceuticals, Inc.,

and Proctor for Linx/Johnson & Johnson, JMM—Consultant for Boston

Scientific, and US Endoscopy.

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Authors and Af_f_iliations

Bethanyuni00A0J.uni00A0Slater

1

uni00A0· Ameliauni00A0Collings

2

uni00A0· Rebeccauni00A0Dirks

2

uni00A0· Jonuni00A0C.uni00A0Gould

3

uni00A0· Aliauni00A0P.uni00A0Qureshi

4

uni00A0· Ryanuni00A0Juza

5

uni00A0·

Maríauni00A0Ritauni00A0Rodríguez-Luna

6

uni00A0· Claireuni00A0Wunker

7

uni00A0· Geof_freyuni00A0P.uni00A0Kohn

8

uni00A0· Shanuuni00A0Kothari

9

uni00A0· Elizabethuni00A0Carslon

10

uni00A0·

Stephanieuni00A0Worrell

11

uni00A0· Ahmeduni00A0M.uni00A0Abou-Setta

12

uni00A0· Mohammeduni00A0T.uni00A0Ansari

13

uni00A0· Dimitriosuni00A0I.uni00A0Athanasiadis

2

uni00A0· Shaununi00A0Daly

14

uni00A0·

Francescauni00A0Dimou

15

uni00A0· Ivyuni00A0N.uni00A0Haskins

16

uni00A0· Julieuni00A0Hong

17

uni00A0· Kumaruni00A0Krishnan

18

uni00A0· Anneuni00A0Lidor

5

uni00A0· Virginiauni00A0Litle

19

uni00A0· Donalduni00A0Low

10

uni00A0·

Anthonyuni00A0Petrick

20

uni00A0· Ianuni00A0S.uni00A0Soriano

21

uni00A0· Niravuni00A0Thosani

22

uni00A0· Amyuni00A0Tyberg

23

uni00A0· Vicuni00A0Velanovich

24

uni00A0· Ramonuni00A0Vilallonga

25

uni00A0·

Jef_freyuni00A0M.uni00A0Marks

26

1

University ofuni00A0Chicago Medicine, 5841 S. Maryland Avenue,

MC 4062, Chicago, IL, USA

2

Department ofuni00A0Surgery, Indiana University School

ofuni00A0Medicine, Indianapolis, IN, USA

3

Division ofuni00A0Minimally Invasive anduni00A0Gastrointestinal Surgery,

Department ofuni00A0Surgery, Medical College ofuni00A0Wisconsin,

Milwaukee, WI, USA

4

Division ofuni00A0General & GI Surgery, Foregut Surgery, Oregon

Health & Science University, Portland, OR, USA

5

Department ofuni00A0Surgery, University ofuni00A0Wisconsin, Madison,

WI, USA

6

Research Institute Against Digestive Cancer (IRCAD)

anduni00A0ICube Laboratory, Photonics Instrumentation foruni00A0Health,

Strasbourg, France

7

Saint Louis University, Stuni00A0Louis, MO, USA

8

Department ofuni00A0Surgery, Monash University, Melbourne, VIC,

Australia

9

Department ofuni00A0Surgery, Prisma Health, Greenville, SC, USA

10

Virginia Mason Medical Center, Seattle, WA, USA

11

University ofuni00A0Arizona Health Sciences, Tucson, AZ, USA

12

Department ofuni00A0Community Health Sciences, University

ofuni00A0Manitoba, Winnipeg, Canada

13

School ofuni00A0Epidemiology anduni00A0Public Health, University

ofuni00A0Ottawa, Ottawa, Canada

14

Department ofuni00A0Surgery, University ofuni00A0California, Irvine,

Orange, CA, USA

15

Washington University inuni00A0St. Louis, St.uni00A0Louis, MO, USA

16

Department ofuni00A0Surgery, University ofuni00A0Nebraska Medical

Center, Omaha, USA

17

Department ofuni00A0Surgery, New York Presbyterian/Queens,

Queens, USA

18

Massachusetts General Hospital, Boston, MA, USA

19

Section ofuni00A0Thoracic Surgery, Department ofuni00A0Cardiovascular

Surgery, Intermountain Healthcare, Saltuni00A0Lakeuni00A0City, UT, USA

20

Department ofuni00A0General Surgery, Geisinger School

ofuni00A0Medicine, Geisinger Medical Center, Danville, PA, USA

21

Department ofuni00A0Surgery, University ofuni00A0California San

Francisco School ofuni00A0Medicine, Sanuni00A0Francisco, CA, USA

22

McGovern Medical School, Center foruni00A0Interventional

Gastroenterology atuni00A0UTHealth, Houston, TX, USA

23

Rutgers Robert Wood Johnson Medical School,

Newuni00A0Brunswick, NJ, USA

24

Division ofuni00A0Gastrointestinal Surgery, Tampa General, Tampa,

FL, USA

25

Endocrine, Metabolic anduni00A0Bariatric Unit, General Surgery

Department, Vall d’Hebron University Hospital, Center

ofuni00A0Excellence foruni00A0theuni00A0EAC-BC, Universitat Autònoma de

Barcelona, Barcelona, Spain

26

Case Western Reserve University School ofuni00A0Medicine,

University Hospitals Cleveland Medical Center, Cleveland,

OH, USA

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