Introduction: Laparoscopic sleeve gastrectomy (LSG) is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The role of crural repair during LSG is still controversial. The preoperative laxity of the gastroesophageal junction (GEJ), graded by Hill’s classification, is more predictive for postoperative GERD and EE after LSG than the presence of a hiatal hernia seen on endoscopy. Thus, the authors hypothesize that a concomitant crural repair in a specific subgroup of patients with a lax GEJ (Hill’s III) may reduce the incidence of postoperative GERD and EE. Methods: A double-blinded, randomized controlled trial of patients with Hill’s III GEJ undergoing LSG will be randomized to a concomitant crural repair (experimental) versus LSG alone (control). Primary outcome measures will be presence of EE at 1 year. Secondary outcome measures will include proton pump inhibitor use, postoperative complications, operative time, blood loss, quality of life, GERD, and gastrointestinal symptoms. Conclusion: Conflicting crural repair results may be explained by differences in preoperative GEJ laxity. Patients with a frank hiatal hernia and patulous GEJ (Hill’s IV) have a very high, while patients with an apposed GEJ (Hill’s I, Hill’s II) have a low incidence of postoperative GERD and EE, respectively. Thus, the authors hypothesize that patients with a lax GEJ without frank hiatal hernia (Hill’s III) might benefit from a crural repair. This study results can potentially highlight the clinical importance of preoperative endoscopic evaluation of the GEJ in all patients planned for LSG to determine which subgroup of patients may benefit from a crural repair (Clinicaltrials.gov: NCT05330910, registered on 15 April 2022).

The increasing prevalence of obesity and diabetes mellitus worldwide is becoming an ever-increasing global public health issue, with increased healthcare costs, disease-related morbidity, and decreased life expectancy [1]. For many patients, bariatric surgery is not only capable of ameliorating or reversing the metabolic complications of obesity and metabolic syndrome but also of improving survival [2]. Laparoscopic sleeve gastrectomy (LSG) has become the most frequently performed bariatric procdure worldwide [3]. This is attributed to its technical simplicity [4], avoidance of an intestinal bypass [5], and its demonstrated cost-effectiveness [6] when compared to the gold standard laparoscopic Roux-en-Y gastric bypass (LRYGB), with relatively comparable weight loss and metabolic outcomes [7, 8].

Yet, a significant limitation of LSG is the potential development of de novo gastroesophageal reflux disease (GERD) and erosive esophagitis (EE), or the exacerbation of pre-existing GERD or EE [9, 10]. Among the risk factors for postoperative GERD and EE is the presence of a hiatal hernia [11]. In the First International Consensus Conference for gastroesophageal reflux and LSG, 66.7% and 80% of surgeons surveyed will elect to perform a crural repair for patients with an asymptomatic small or large hiatal hernia, respectively [9]. Though numerous studies have reported an improvement in postoperative GERD [12], this was not shown in the only randomized controlled trial, which reported no significant differences in GERD outcomes with or without a concomitant crural repair [13].

The trial, however, suffered from several limitations. First, it included both patients with and without a hiatal hernia, and this factor itself was non-randomly distributed between the intervention and control groups [13]. Second, the primary outcome measure was subjective, though the effects were mitigated as patients were blinded [13]. Third, the assessment of hiatal hernia via the axial length is known to be operator-dependent as well as subject to changes between inspiration and expiration, which can make its assessment less objective [14]. Lastly, based on their analysis, there appeared to be a 2-point difference in the crural repair arm, regardless of the presence or absence of a hiatal hernia, though this did not reach statistical significance [13]. Furthermore, the power calculations in the trial were based on improvements in Gastrointestinal Symptom Rating Scale (GSRS) scores [15] seen following a Nissen’s fundoplication procedure on patients with primary GERD and not on bariatric surgery patients [13]. Thus, the trial findings, though useful, may result in a bias toward the null hypothesis as a result [13].

The authors recently published their retrospective review of their center’s LSG outcomes [10]. To the best of the authors’ knowledge, this study represented the first to establish a correlation between the laxity of the gastroesophageal junction (GEJ), assessed using Hill’s classification [16], and postoperative GERD and EE at up to 1-year follow-up. The study findings provided fresh insights into the risk factors associated with postoperative GERD and EE. It was observed that all patients with a frank hiatal hernia (Hill’s IV) and more than half of patients with a lax GEJ (Hill’s III) developed postoperative GERD and EE, respectively, in contrast to patients with lower Hill’s grades (Hill’s I and Hill’s II). The authors wonder whether the contentious outcomes of a crural repair may be attributed to patient selection, suggesting that only patients with a lax GEJ will significantly benefit from such a repair.

Therefore, the hypothesis underlying this clinical trial posits that a concomitant crural repair, when performed in patients with a preoperatively identified lax GEJ (Hill’s III) alongside LSG, will result in a significant improvement in postoperative EE and GERD. The main outcome measure of this clinical trial is the incidence of postoperative EE at 1-year post-surgery on routine postoperative esophagogastroduodenoscopy (EGD) and grading the severity of EE on the Los Angeles classification system [17]. The secondary outcome measures include the incidence of GERD symptoms, graded with the GSRS, as well as the quality of life in reflux and dyspepsia questionnaire (QOLRAD) [18, 19], dysphagia symptoms graded on the GSRS scale, and quality of life scores measured on the SF-36 questionnaire. These secondary outcomes are assessed at 3, 6, 9, and 12 months postoperatively. Additional secondary outcome measures included postoperative complications, operative time, blood loss, persistence of proton pump inhibitor use after surgery, incidence of revision surgery at 1 year and postoperative weight loss at 1 year.

Study Design and Registration

This clinical trial was a double-institution, double-blinded, randomized controlled study conducted by surgeons from the Upper Gastrointestinal and Bariatric Service within the Departments of General Surgery at Sengkang General Hospital (SKH) and of Upper Gastrointestinal and Bariatric Surgery at Singapore General Hospital (SGH). It has received approval from the Institutional Review Board (SingHealth Centralised Institutional Review Board, Ref: 2022/2028) and is currently in the recruitment phase. The trial has been registered on ClinicalTrials.gov with the identifier NCT05330910.

Study Population

Patient inclusion and exclusion criteria were summarized in Table 1. Eligible patients have been recruited from the bariatric surgery consultation clinics at both institutions. As part of their standard preoperative assessment, patients considered suitable candidates for bariatric surgery will invariably undergo a routine EGD.

Table 1.

Table summarizing the inclusion and exclusion criteria of patients in the clinical trial

Inclusion criteria 
 Aged >21 years old 
 Hill’s III GEJ 
 Consented to undergo LSG 
 Able to provide informed consent 
Exclusion criteria 
 Contraindications to LSG 
 Opted not to undergo LSG 
 Had previous upper gastrointestinal surgery 
 Had previous laparoscopic adjustable gastric banding procedure 
 Has a Hill’s I or II GEJ 
 Presence of a pathological hiatal hernia, defined on axial length to be >2 cm, or Hills’ IV 
 Presence of EE on preoperative endoscopy 
 Unable or unwilling to provide informed consent 
Inclusion criteria 
 Aged >21 years old 
 Hill’s III GEJ 
 Consented to undergo LSG 
 Able to provide informed consent 
Exclusion criteria 
 Contraindications to LSG 
 Opted not to undergo LSG 
 Had previous upper gastrointestinal surgery 
 Had previous laparoscopic adjustable gastric banding procedure 
 Has a Hill’s I or II GEJ 
 Presence of a pathological hiatal hernia, defined on axial length to be >2 cm, or Hills’ IV 
 Presence of EE on preoperative endoscopy 
 Unable or unwilling to provide informed consent 

GEJ, gastroesophageal junction; LSG, laparoscopic sleeve gastrectomy; EE, erosive esophagitis.

Patient Group Selection

Patients with pre-existing Hill’s III GEJ were identified as the group of interest in this study for several reasons. Based on the authors reported findings [10], all patients with Hill’s IV GEJ developed postoperative GERD and EE. Given the high likelihood of GERD and EE in Hill’s IV GEJ patients, the authors believed they should be better served with an alternative bariatric procedure instead with a reduced incidence of GERD and EE, such as a LRYGB. Thus, the authors have excluded all of Hill’s IV patients from a crural repair. Thus, this further reinforced the rationale for adopting Hill’s classification system rather than the axial length measurement, as all patients with a pathologic hiatal hernia (Hill’s IV) were not included in this study.

Hill’s I and Hill’s II patients were excluded from this study due to the following reasons. Patients with Hill’s I have an anatomically intact gastroesophageal flap valve. Furthermore, based on the authors’ published results, the incidence of GERD and EE in this group of patients was 7.0% and 21.1%, respectively, which was much lower than the incidence reported in the literature [20‒22]. It was felt that a complete hiatal dissection, followed by a standard crural repair, in this group of patients would unnecessarily disrupt their anatomically intact gastroesophageal flap valve and ironically result in an increased incidence of GERD and EE postoperatively. Hill’s II patients were also excluded from this study for 2 reasons. Based on the authors’ experience, Hill’s II GEJ can be subjective and may be subject to respiratory variation, in contrast to Hill’s III GEJ which is easily recognizable by a gap between the GEJ and the endoscope on retroflexion with the stomach fully distended [14]. Thus, in this study, Hill’s III patients were selected with the intention of evaluation if a crural repair may help reduce the incidence of postoperative EE to that seen in patients with an intact gastroesophageal flap valve. Thus, the study aimed to recruit all patients with Hill’s III GEJ flap valve without EE.

Outcome Measures

The primary outcome measure evaluated was the presence of EE and its grading based on the Los Angeles classification. This outcome measure was chosen because it relies on objective endoscopic grading assessments rather than subjective patient-reported scales. Furthermore, the endoscopic assessment allows for blinding of the endoscopist at the postoperative 1-year EGD, which reduces reporter bias.

The GSRS was selected to evaluate the secondary outcome measure as it has been evaluated in patients after LSG [13]. In addition, on top of evaluating symptoms of GERD, it allows for the evaluation of symptoms of dysphagia, which may be a potential adverse effect as a result of an excessively tight crural repair. Given that the incidence of EE on EGD is almost 5 times less common in patients treated with proton pump inhibitors compared to those who are not [23], the QOLRAD questionnaire was added to add a second layer of resolution, as this questionnaire was validated for the assessment of GERD, particularly in patients who may be on proton pump inhibitors [19], which may be common in patients who developed GERD symptoms. The last secondary outcome measure was the persistence of proton pump inhibitor use after the initial postoperative protocol of 6-week duration.

Surgical Technique and Postoperative Care

A standardized surgical technique was employed, as had been previously described [10], involving a 40Fr bougie and a standard 5-port LSG. For patients randomized to the concomitant crural repair group, a posterior crural repair will be performed. The technique for a posterior cruroplasty has been previously described [24‒26], which involved a pars flaccida incision followed by a complete hiatal dissection to mobilize the abdominal esophagus from the right and left crus. Subsequently, the hiatal gap between the left and right crus is apposed primarily with a non-absorbable braided suture, with the exception that the repair will be done in an interrupted manner, as these patients likely do not have a huge hiatal gap to permit a continuous suture fashion as initially described by Cuschieri et al. [24, 26]. Intraoperative details including operative time, blood loss, and postoperative complications will be noted.

Standard protocolized postoperative recovery for all bariatric patients was employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after. All patients were discharged once they were hemodynamically normal and able to tolerate at least 1 L of oral liquids per day with no other surgical complications, most commonly within the 1st or 2nd postoperative day.

All patients were prescribed proton pump inhibitors at 40 mg twice a day for a total of 6 weeks postoperatively, as part of routine postoperative protocol, which was then discontinued. Patients who were deemed symptomatic during their subsequent follow-up visits with their primary surgeon and required addition proton pump inhibitor pharmacotherapy after the initial 6 weeks after surgery were noted.

Patients were reviewed in clinic postoperatively at 2 weeks after surgery, followed by follow-up outpatient visits at 3, 6, 9, and 12 months. All patients would consent to undergo a postoperative EGD after their 12-month visit. During the clinic visits at 3, 6, 9, and 12 months, they were given the SF-36, QOLRAD, and GSRS questionnaires for assessment. Anthropometric measurements were taken during each visit.

Recruitment, Randomization, and Blinding

All patients fulfilling inclusion criteria were approached for recruitment after their preoperative EGD. Randomization was carried out using a block-of-4 randomization method. Block randomization was selected, given the small study size, to ensure equal representation in both arms of the study. Allocation concealment was achieved via a central computer-generated random assignment, with participants from both institutions being randomized through the same central assignment. Allocation was only made known to the surgeon after the patient was induced on the table prior to surgery.

This study is a double-blinded randomized controlled trial. Participants were blinded for the entire duration of the study, and their allocation would only be made known to them at the conclusion of the study at the end of 1 year postoperatively, after they had completed their postoperative 1-year EGD. Assessor blinding was also performed as the endoscopist performing the postoperative 1-year EGD was also blinded to the initial group assignment of the patient.

Power Calculations

Based on the authors’ previous review, the incidence of postoperative EE in Hill’s III GEJ was 68.8% [10]. A conservative estimate of at least 65% was taken as the incidence of postoperative EE in the patients with Hill’s III. The combined incidence of postoperative EE in Hill’s I and Hill’s II was 33.3% [10]. Thus, a reduction in postoperative EE to an incidence of 30% was taken as the anticipated incidence of EE after a cruroplasty, similar to patients with a Hill’s I or Hill’s II GEJ.

Thus, assuming a 65% incidence in the control arm and a 30% incidence in the interventional arm, with a significance level of 5% and power of 80%, 74 patients will be required in total, with 37 patients in each arm. Assuming a 25% loss to follow-up rate, and in order to preserve the integrity of the block-of-4 randomization, a total of 96 patients would be recruited for this trial, with 48 patients in each arm.

Data Analysis

Data would be analyzed via SPSS statistical software. Categorical data are represented as n (%) and analyzed via χ2 analysis. Non-parametric data are presented by the median with interquartile ranges and analyzed via the Mann-Whitney U test, while parametric data are presented as their mean with standard deviation and analyzed via the Student’s t test. Multivariate analysis would be performed via binomial logistical regression. Survival analysis would also be performed to estimate the time to the development of reflux symptoms or erosive esophagitis during follow-up.

The results of this two-center, double-blinded, randomized controlled trial, would help shed light on the controversial debate on the role of a crural repair during LSG. This study would also provide class I evidence on the role of the gastroesophageal flap valve in preventing GERD and EE after LSG. This may lead to the development of stratified approaches, based on the laxity of the GEJ, in the selection of patients for LSG.

Trial Status

The trial was registered on 15 April 2022, at ClinicalTrials.gov under identifier NCT05330910. It is currently recruiting and is anticipated to be completed by April 2028.

The authors would like to thank the study biostatistician, Ms. Tan Hui Cheng, for her aid in the power calculations.

This study protocol was reviewed and approved by the Institutional Review Board, approval number (SingHealth Centralised Institutional Review Board Ref: 2022/2028). Written informed consent was obtained from all participants, and research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

The authors declare no conflict of interest.

This work was supported by the SingHealth Surgery Academic Clinical Programme Budding Researcher Grant as well as the Sengkang General Hospital Internal Research Grant.

Koy Min Chue: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing – original draft, writing – review and editing, visualization, supervision, project administration, and funding acquisition. Bin Chet Toh, Lester Wei Lin Ong, Gamage Manisha Daminda Kariyawasam, Wai Keong Wong, and Chin Hong Lim: conceptualization, methodology, resources, writing – review and editing, visualization, supervision, and project administration. Jeremy Tian Hui Tan: conceptualization, methodology, resources, data curation, writing – review and editing, visualization, supervision, and project administration. Baldwin Po Man Yeung: conceptualization, methodology, investigation, resources, data curation, writing – original draft, writing – review and editing, visualization, supervision, project administration, and funding acquisition.

Additional Information

All authors are in agreement with the contents of the manuscript.

As this publication is a trial protocol, no data are available as trial is still ongoing. The authors anticipate that upon completion of the trial, trial results will be published subsequently. Further inquiries can be directed to the corresponding author.

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