Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy

Study Overview
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Brief Summary
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The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are: Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.

Detailed Description
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Laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric procedure worldwide. LSG consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. However, gastro-esopageal reflux disease (GERD) has been reported to increase after LSG. Our hypothesis is that GERD is mainly due to intrathoracic migration of the gastric remnant. The aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux. Patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. According to power calculations a total of 550 patients will be randomized in the study. Follow-up will be at six weeks, one-, two- and five years.

Official Title
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A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Sleeve gastrectomy with gastropexy
* Procedure: Sleeve gastrectomy without gastropexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for bariatric surgery with primary LSG Exclusion Criteria: Age below 18 yrs Use of ARM for other reasons than reflux Previous antireflux surgery Inability to comprehend and respon to patient related outcome (PRO) questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No gastropexy<br>Sleeve gastrectomy without gastropexy. | Procedure: Sleeve gastrectomy without gastropexy<br>* Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.<br>|
| Experimental: Gastropexy<br>Sleeve gastrectomy with gastropexy | Procedure: Sleeve gastrectomy with gastropexy<br>* Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD | ARM: Daily use of ARM for the last month | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic findings | Visible oesophagitis according to the LA classification | Two years | 
| Patient related outcome | GerdQ questionnaire | Two years | 
| pH-metry | pH measurement by Bravo capsule | Two years |