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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