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https://doi.org/10.1007/s00464-022-09209-7
Received: 7 August 2021 / Accepted: 7 February 2022 / Published online: 12 April 2022
© The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022
Abstract
Background The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed evidence-based guide-
lines for the management of patients with gastroesophageal reflux disease (GERD). The aim of this study is to evaluate guide-
lines lacking agreement among experts (grades B–D) or lacking support from randomized controlled trials (levels II–III).
Methods Six guidelines were chosen for evaluation. A retrospective review of a multicenter database of patients undergoing
fundoplication surgery for treatment of GERD between 2015 and 2020 was performed. Patients that underwent a concurrent
gastrectomy or were diagnosed with pre-operative achalasia were excluded. Demographics, pre-operative, intra-operative,
and post-operative variables were collected. Post-operative outcomes were evaluated based on selected SAGES guidelines.
Outcomes were assessed using multivariable regression or stratified analysis for each guideline.
Results A total of 444 patients from four institutions underwent surgery for the management of GERD with a median (interquartile
range) follow-up of 16 (13) months. Guidelines supported by our data were (1) robotic repair has similar short-term outcomes to
laparoscopic repair, (2) outcomes in older patients are similar to outcomes of younger patients undergoing antireflux surgery, and
(3) following laparoscopic antireflux surgery, dysphagia has been reported to significantly improve from pre-operative values.
Guidelines that were not supported were (1) mesh reinforcement may be beneficial in decreasing the incidence of wrap herniation,
(2) a bougie has been found to be effective, and (3) the long-term effectiveness of fundoplication in obese individuals (BMI > 30)
has been questioned due to higher failure rates.
Conclusion Many SAGES GERD guidelines not receiving Grade A or Level I recommendation are supported by large,
multicenter database findings. However, further studies at low risk for bias are needed to further refine these guidelines.
Graphical abstract
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9346 Surgical Endoscopy (2022) 36:9345–9354
Current studies show mixed results, with some finding no differences and others find-
RCTs have shown possible benefit with mesh reinforcement in reducing wrap hernia-
RCTs have shown a wide range of post-operative dysphagia symptoms but most
The Society of American Gastrointestinal and Endoscopic
Surgeons (SAGES) Guidelines Committee published recom-
mendations for the surgical management of gastroesopha-
intra-operative bougie
this benefit, including a randomized controlled trial which
laparoscopic repair
showed significantly lower recurrence rates for mesh rein-
forcement compared to suture reinforcement at 1 year fol-
low-up (8% vs. 26%, p = 0.001) [2]. Another area of disa-
greement is the benefits of robotic assistance compared to Comment
tion
laparoscopic assistance (grade B). Randomized controlled
trials comparing the two approaches have shown that robotic Mesh reinforcement may be beneficial in decreasing the incidence of wrap herniation
A 56 French bougie has been found to be effective but the evidence is limited (Grade
higher cost compared with conventional laparoscopy and similar short-term patient
repair is significantly more expensive with longer operating
been questioned due to higher failure rates (level II–III) compared with normal
yet to show superior outcomes with use of robotic assis-
tance over laparoscopic repair. Additionally, the impact of
age on outcomes of fundoplication surgery (grade C) lacks
expert certainty. Studies have found that elderly patients
Table 1 SAGES guidelines with limited evidence or expert agreement
Guideline 2
Guideline 3
Guideline 4
Guideline 5
Guideline 6
Guideline
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patients (BMI > 30) to non-obese patients (level II–III). The Table 2 Background and demographics
current research on antireflux surgery in obese patients has Patient variables N = 444
mixed results, with some studies showing higher failure rates
in obese patients [16, 17] and others finding no significant Age, year, mean ± SD 53.8 ± 13.1
differences in outcomes between obese and normal weight Ethnicity, n (%)
patients [18]. African American 40 (9%)
The aim of this study is to assess recommendations lack- Asian 6 (1.4%)
ing the highest level of evidence or endorsement utilizing a Hispanic 114 (25.7%)
large, multicenter database of patients undergoing surgery White 219 (49.3%)
for GERD. Other 65 (14.6%)
Gender, female, n (%) 297 (66.9%)
ASA status, n (%)
Methods 1 7 (1.6%)
2 259 (58.3%)
A multicenter, retrospective review was conducted on all 3 175 (39.4%)
patients who underwent fundoplication surgery from June 4 3 (0.7%)
2015 to March 2020 at one of four institutions (2 private BMI, kg/m2, mean ± SD 29.7 ± 5.3
hospitals, 1 University hospital, and 1 safety-net hospital). COPD, n (%) 15 (3.4%)
All patients undergoing fundoplication surgery for GERD Diabetes mellitus, n (%) 48 (10.8)
were eligible for inclusion. Patients were excluded if they Current smoker, n (%) 40 (9%)
underwent a gastrectomy or were diagnosed with pre-oper- Previous abdominal surgeries, median 0
ative achalasia. Yes, n (%) 195 (43.9%)
Patient variables collected include age, ethnicity, gen-
der, American Society of Anesthesiologists (ASA) status,
body mass index (BMI), chronic obstructive pulmonary t-test or Mann–Whitney U test. When appropriate, mul-
disease, current smoking, and number of previous abdomi- tivariable regression analysis was performed to evaluate
nal surgeries. Variables from pre-operative testing included variables associated with each outcome. Variables included
EGD, gastritis, LA Grade esophagitis, Hill Grade, Barrett’s in the multivariable analysis were chosen a priori and
esophagus. Pre-operative variables recorded were use of included center, age, ethnicity, gender, BMI, diabetes mel-
baseline medications (PPI or H2 blocker use) and self-report litus, COPD, prior surgery, and hiatal hernia. Other vari-
pre-operative symptoms (heartburn, dysphagia, epigastric ables included depending on the guideline were use of mesh,
pain, cough, and regurgitation). All centers used electronic surgical approach, fundoplication type, bougie usage, and
medical records and standardized templates with common pre-operative dysphagia. When there was evidence of col-
questions to review symptoms of dysphagia, heartburn, and linearity or interactions, variables were dropped for model
regurgitation before and after surgery. Operative variables stability. All statistics were performed using Stata v.16.
collected were fundoplication approach, mesh, bougie, fun-
doplication type, and intra-operative EGD. Outcome vari-
ables were surgical site infection, emergency department
visits, Dindo–Clavien outcomes [19], symptom recurrence at Results
last clinic visit (defined as heartburn, dysphagia, epigastric
pain, cough, and/or regurgitation), antacid use at last clinic A total of 444 patients from four institutions underwent sur-
visit, anatomic failure, and reoperation (any time post-oper- gery for the management of GERD with a median (inter-
ative). Post-operative imaging was performed selectively on quartile range) follow-up of 16 (13) months. Patient back-
patients with recurrent symptoms at any follow-up visit. ground and demographics are in Table 2. Many patients were
Additional independent variables were based on the obese (mean BMI 29.7), white (49.3%), and female (66.9%).
SAGES guideline being evaluated and included surgical Over one-third of patients were ASA status of 3–4 (40.1%)
reinforcement (mesh or suture), surgical assistance (robotic and almost half had previous abdominal surgeries (43.9%).
or laparoscopic), pre-operative dysphagia, patient age (over Results of pre-operative evaluation are in Table 3. Fifty-
65 years), patient BMI (over 30), and intra-operative bougie five patients (12.8%) had esophagitis identified on pre-
usage. Follow-up duration was defined as the most recent operative EGD while 209 (48.7%) patients had a Hill Grade
clinical evaluation. 2–4. Most patients were taking a PPI preoperatively (80.9%)
Categorial outcomes were assessed by Fisher exact test, or other antacid (18.2%). All patients reported heartburn
and continuous outcomes were assessed using two-tailed
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operative candidates, as outcomes in this patient group are to their younger counterparts (5.8% vs. 26.3%, p < 0.001).
similar to outcomes of younger patients (Grade C). Outcome On regression analysis, patients over 65 years old did not
analysis is in Table 9. Compared to younger patients, patients have significant differences in occurrence of Dindo–Clavien
over 65 years old had similar occurrence of Dindo–Clavien complications compared to patients less than 65 (OR 1.00,
outcomes (cumulative 14.4% vs. 10.3%, p = 0.597) and 95% CI 0.97–1.03, p = 0.950).
dysphagia symptoms at last clinic visit (14% vs. 15.4%, SAGES guideline A 56 French bougie has been found
p = 0.741). Patients over 65 also reported significantly lower to be effective but the evidence is limited (Grade C). Out-
heartburn symptom recurrence at last clinic visit compared come analysis is in Table 10. Patients that received an
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Table 10 Bougie efficacy
Univariate analysis
Bougie efficacy Bougie, yes Bougie, no p-value
(N = 76) (N = 368)
intra-operative bougie had no significant differences in significant difference for fundoplication type between the
post-operative Dindo–Clavien outcomes (cumulative 5.2% two groups, with the majority receiving a partial fundopli-
vs. 12.4%, p = 0.295), heartburn symptoms at last clinic cation (67.5% vs. 63.5%, p = 0.377). Post-operative results
visit (17.6% vs. 23.1%, p = 0.294), dysphagia symptoms at were similar to non-obese patients for Dindo–Clavien out-
last clinic visit (18.9% vs. 14.3%, p = 0.312), or reoperation comes (cumulative 9.9% vs. 12.4%, p = 0.863), dysphagia
(7.9% vs. 4.6%, p = 0.241). However, the patients that had symptoms at last clinic visit (13.3% vs. 16.7%, p = 0.329),
an intra-operative bougie had significantly lower rates of anatomic failure (16.3% vs. 15.8%, p = 0.899), and reopera-
anatomic failure (7.9% vs. 17.7%, p = 0.034). On regression tion (5.4% vs. 5%, p = 0.835). Additionally, obese patients
analysis, usage of a bougie did not result in significantly were less likely to report heartburn symptoms at last clinic
lower rates of post-operative dysphagia (OR 1.10, 95% CI visit when compared to non-obese patients (15.8% vs.
0.33–3.26, p = 0.859). 27.6%, p = 0.003). On regression analysis, obese patients did
SAGES guideline Following laparoscopic antireflux not have significantly higher incidence of wrap herniation
surgery, dysphagia has been reported to significantly (OR 1.00, 95% CI 0.95–1.06, p = 0.910).
improve from pre-operative values (level II–III). A total of
178 patients reported dysphagia preoperatively. Of these
patients, 83.6% stated that their symptoms had resolved by Discussion
their last clinic visit. Prior to surgery, 266 patients reported
no dysphagia symptoms. Of these patients, 14.3% were There is a lack of consensus and/or evidence at low risk for
experiencing dysphagia symptoms at their last clinic visit. bias to support several of the SAGES GERD guidelines.
There was no significant difference between the two groups Many studies cited on the management of GERD have small
for prevalence of post-operative dysphagia (16.4% vs 14.3%, sample size, limited follow-up, and heterogeneity in outcome
p = 0.498). reporting [18]. In addition, variations in surgical technique
SAGES guideline The long-term effectiveness of fun- and reporting of surgical technique limits study generaliza-
doplication in obese individuals (BMI > 30) has been ques- bility. Our study provides multicenter data including surgical
tioned due to higher failure rates compared with normal details and outcomes details not available in many nation-
weight patients. Nevertheless, others have reported equiva- wide databases. It augments smaller randomized controlled
lent outcomes in obese and normal weight individuals (level trials by providing real-world effectiveness data that can
II–III). Outcome analysis is in Table 11. The mean BMI for increase the strength and generalizability of recommenda-
patients with BMI > 30 was 34.2 while the mean BMI for tions made. While randomized controlled trials are needed
patients with BMI ≤ 30 was 25.8 (p < 0.001). There was no whenever feasible often we need to simply rely on the best
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available data to guide treatment strategies. SAGES GERD of Dindo–Clavien complications in patients repaired with
guidelines are currently in the process of being updated to mesh compared to those without. Surgeons may have chosen
support more recent literature. mesh reinforcement for the more complex cases, leading
Three of the SAGES guidelines were not supported by to a higher incidence of Dindo–Clavien outcomes in this
our study. Obese patients (BMI > 30) had similar post- group. However, the similar anatomic failure rates between
operative outcomes to patients with BMI ≤ 30, including patients with and without mesh reinforcement requires fur-
wrap herniation. Prior research has shown mixed results ther evaluation. This indicates that use of mesh may not be
of fundoplication surgery for GERD among obese patients as beneficial to fundoplication surgery as previously thought.
[16–18, 20]. However, even among the studies demonstrat- The type of mesh used also needs to be taken into considera-
ing similar outcomes between obese and non-obese patients, tion. The majority of mesh used in our study was biologic
obese patients were reported technically more challenging mesh (98.3%). Thus far, biologic mesh has had less reported
and required longer operative duration [20]. It is possible complications compared to synthetic mesh [21]. However,
that the differences among these studies were due to differ- there has not been sufficient evidence to support biologic
ences in surgeon experience given that fundoplication with mesh in improving long-term hernia recurrence rates [22].
obese patients is technically more complex. Alternatively, We acknowledge several limitations to our study. Most
there could be selection bias as surgeons selectively chose importantly, our study is limited in that it is a retrospec-
which obese patients to operate on versus not operate on. tive review. Therefore, the decision for mesh placement,
Another unexpected finding was the lack of benefit from bougie placement, and partial/complete wrap is indi-
an intra-operative bougie in reducing post-operative dys- vidualized based on surgeon preference and the rea-
phagia [10]. This may be due to experienced surgeons no soning is not retrievable through chart review. Another
longer needing a bougie to gauge an appropriate wrap size. piece of information that was not retrieved through chart
Another possible reason for these findings could be the shift review is OR duration. This is especially relevant when
in preference toward a partial fundoplication approach over comparing robotic to laparoscopic assistance, as ran-
a complete fundoplication, rendering an intra-operative domized controlled trials have found robotic assistance
bougie less important. Our findings also differed from the to be more expensive and associated with longer operat-
randomized controlled trial evaluating the use of mesh [2], ing times [3–6]. It is possible the longer operating times
as we found similar hernia recurrence but higher incidence associated with robotic assistance will improve over time
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s11605-007-0195-y Publisher's Note Springer Nature remains neutral with regard to
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https://doi.org/10.1007/s00464-002-8910-y
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* Cassandra Mohr Department of Surgery, University of Kentucky, Lexington,
cassandra.a.mohr@uth.tmc.edu KY, USA
4
1 Department of Surgery, HCA Healthcare Kingwood,
Department of Surgery, McGovern Medical School,
University of Houston, Kingwood, TX, USA
Houston, TX, USA
5
2 Department of Surgery, Lyndon B. Johnson Hospital, 5656
Department of Surgery, New Hanover Regional Medical
Kelley St, Houston, TX 77026, USA
Center, Wilmington, NC, USA
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