Clinical trial NCT05330910: Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Official title: A Randomized Controlled Trial Evaluating PAtients With Lax Gastroesophageal Junction to Initial Sleeve Gastrectomy With or Without Concomitant Crural Repair (REPAIR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Esophagus Injury
Gastroesophageal Reflux
Keywords: Obesity
Bariatric Surgery
Esophagitis
Gastroesophageal reflux disease
Laparoscopic sleeve gastrectomy
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2022-04-15
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a double institution, double-blinded, randomized controlled trial, involving surgeons from the Upper Gastrointestinal and Bariatric Service, Department of General Surgery, Sengkang General Hospital (SKH) as well as the Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital (SGH).

Randomization will be performed by block randomization, with each block of 4. Block randomization was selected given the small study size, to ensure equal representation in both arms of the study.
Primary purpose: TREATMENT

Brief summary: Background:

Laparoscopic sleeve gastrectomy (LSG) is one of the commonest bariatric procedures. However, it is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The investigators' preliminary study suggests that the incidence of postoperative GERD and EE appears to be correlated with the preoperative presence of a lax gastroesophageal flap valve and hiatal hernia.

Hypothesis/ Aim:

To investigate the impact of a concomitant hiatal hernia repair with LSG on the incidence of postoperative EE.

Significance:

For patients with pre-existing EE, most surgeons will recommend a laparoscopic Roux-en-Y gastric bypass (LRYGB) as their primary bariatric procedure. However, compared to LSG, LRYGB is a technically more demanding procedure with increased morbidity and long term nutritional deficiencies. For asymptomatic patients at risk of postoperative EE due to presence of a hiatal hernia, there is still no consensus on the most appropriate bariatric surgical option. A LSG with a concomitant hiatal hernia repair, if shown to reduce EE postoperatively, may help to expand the pool of patients suitable for LSG in the future.

Methods:

A two center, double-blinded, randomized controlled trial of all patients, undergoing LSG with a preoperative diagnosis of a Hill's grade III gastroesophageal junction, will be randomized to having a concomitant hiatal hernia repair (experimental arm) versus just LSG alone (control arm). Primary outcome measures include 1-year postoperative EE on endoscopy. Secondary outcome measures include postoperative morbidity, blood loss, quality of life and GERD symptoms at 1-year postoperatively.

Detailed description: Laparoscopic sleeve gastrectomy (LSG) is one of the most common bariatric procedures performed worldwide, accounting for more than 50% of all bariatric procedures, and with respectable weight loss and metabolic benefits which are comparable to the gold standard laparoscopic Roux-en-Y gastric bypass. However, one of the main disadvantages of LSG is its tendency to cause post-operative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE).

To date, it is widely accepted that LSG should be avoided for patients with underlying GERD or EE. However, there is no consensus for asymptomatic patients, including those with an underlying hiatal hernia, which is known to predispose to GERD.

Currently, the two commonly employed methods for endoscopic classification of a hiatal hernia are via its axial length, or by grading the gastroesophageal flap valve, better known as the Hill's classification system.

Multiple retrospective cohort studies have documented a reduction in postoperative GERD following a concomitant LSG with a hiatal hernia repair, in patients with a preoperative diagnosed hiatal hernia. However, to date, there is only one randomized controlled trial which compared the efficacy of concomitant LSG with or without a concomitant hiatal hernia repair. Of the 100 patients, the trial did not report any differences in the incidence of postoperative GERD between the 2 groups. However, the trial had several limitations. Firstly, it included patients with no underlying hiatal hernia. In fact, of the 100 patients, 25 of them have no underlying hiatal hernia, thus may favour the outcome towards the null hypothesis. Subsequently, though the study attempted to randomize participants, while most baseline characteristics are well randomized, the most crucial element in the study, which was the length of the hiatal hernia, was significantly different between the 2 groups. Thirdly, the primary outcome was a subjective score via the Gastrointestinal Symptom Rating Scale (GSRS). Lastly, assessment of the presence of a 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.

The investigators' propose using the alternative classification system for grading a hiatal hernia, called the Hill's classification system, to determine the preoperative hiatal laxity of the gastroesophageal flap valve, to determine which patients will likely benefit from a LSG with a concomitant hiatal hernia repair. The system, first introduced by Hill et al in 1996, was derived from an observational study of 13 cadavers to determine the presence of an anti-reflux valve and hiatal hernia. In the absence of a hiatal hernia, the angle of His, defined as the acute angulation along the greater curve of the stomach where the esophagus enters the stomach, creates a flap valve mechanism. This laxity of this flap valve varies and can be objectively graded based on the Hill's classification. This classification has been shown to be superior to the axial measurement of a hiatal hernia in the endoscopic assessment of the gastroesophageal junction and its association with GERD.

The Hill's classification system is much more objective. The grade III gastroesophageal junction is easily and objectively assessed, with little inter-observer variability, by the presence of a failure of closure of the endoscope around the hiatus. Unlike patients with Hill's grade IV gastroesophageal junction with a frank hiatal hernia, these patients with a grade III gastroesophageal junction mainly have a lax junction, with at most a physiological (\<3cm) hiatal hernia on axial length.

Thus, this study proposes using the Hill's classification system to assess the efficacy of a concomitant crural repair with LSG in patients with a lax gastroesophageal flap valve. The investigators' hypothesize that a select group of patients with an underlying lax gastroesophageal junction may benefit from a concomitant crural repair with LSG. This group of patients, with grade III gastroesophageal junction, who have a lax hiatus and a small or physiological hiatal hernia, may potentially the only patient group that may benefit from a laparoscopic hiatal hernia or crural repair.

Study design:

This study will be a double institution, double-blinded, randomized controlled trial, involving surgeons from the Upper Gastrointestinal and Bariatric Service, Department of General Surgery, Sengkang General Hospital (SKH) as well as the Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital (SGH).

Study population:

Eligible patients will come from patients visiting the bariatric surgery consultation clinic from both SKH and SGH. Patients that are deemed eligible for bariatric surgery will always undergo a routine esophagogastroduodenoscopy as part of standard preoperative evaluation. Patients found on esophagogastroduodenoscopy preoperatively to have a Hill's grade 3 gastroesophageal flap valve, with no evidence of EE will then be recruited.

Included patients should be patients aged between 21-65 years old, able to provide informed consent, with Hill's grade III gastroesophageal junction, that have opted to undergo LSG.

Excluded patients will include patients who are unable or unwilling to provide informed consent, with contraindications to LSG, who have opted not for LSG, who had previous upper gastrointestinal surgery, who have preoperative documented EE on endoscopy, who are graded Hill's grade I, II or IV gastroesophageal junction on retroflexion view of the endoscope with the stomach fully distended.

Randomization:

Patients will be blinded to their randomization allocation. Their allocation will only be made known should there be any adverse event, as per ethical guidelines, or after their end of 1-year follow-up.

Outcome measures:

Primary outcome measures will be presence of EE at the end of their 1-year follow-up after 1-year endoscopy. Secondary outcome measures will include any differences in SF-36 quality of life questionnaire, differences in their Gastrointestinal Symptom Rating Scale, as well as a Quality of Life in Reflux and Dyspepsia questionnaire.

Eligibility criteria: Inclusion Criteria:

* 21-65 years old
* Able to provide informed consent
* Hill's grade III gastroesophageal junction on preoperative endoscopy
* Opted to undergo laparoscopic sleeve gastrectomy as their bariatric procedure

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Contraindications to laparoscopic sleeve gastrectomy
* Opted not to undergo laparoscopic sleeve gastrectomy
* Had previous upper gastrointestinal surgery
* Had documented erosive esophagitis on preoperative endoscopy
* Had Hill's grade I, II or IV gastroesophageal junction on preoperative endoscopy

Primary outcomes:
measure: Presence or absence of post-operative erosive esophagitis
timeFrame: 1-year
measure: Degree of Post-operative erosive esophagitis
timeFrame: 1-year
Secondary outcomes:
measure: General Quality of Life Scores
timeFrame: 3-month, 6-month, 9-month, 1-year
measure: Gastroesophageal reflux disease symptoms
timeFrame: 3-month, 6-month, 9-month, 1-year
measure: Dysphagia symptoms
timeFrame: 3-month, 6-month, 9-month, 1-year
measure: Gastrointestinal reflux disease specific quality of life scores
timeFrame: 3-month, 6-month, 9-month, 1-year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
affiliation: Sengkang General Hospital
name: Baldwin Po Man Yeung, MBChB, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Jeremy Tian Hui Tan, MBBS, FRACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sengkang General Hospital
name: Koy Min Chue, MBBS, FRCSEd
role: PRINCIPAL_INVESTIGATOR
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