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

Not Applicable

Recruiting

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Sleeve gastrectomy without gastropexy; Procedure: Sleeve gastrectomy with gastropexy

• Registration Number: NCT05704348
• Lead Sponsor: Helse Forde

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-09-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2027-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No gastropexy	Sleeve gastrectomy without gastropexy	Sleeve gastrectomy without gastropexy.
Gastropexy	Sleeve gastrectomy with gastropexy	Sleeve gastrectomy with gastropexy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Endoscopic findings	Two years	Visible oesophagitis according to the LA classification
Patient related outcome	Two years	GerdQ questionnaire
pH-metry	Two years	pH measurement by Bravo capsule

Trial Locations

Locations (4)

Aleris Oslo; 🇳🇴 Oslo, Norway

Volda sjukehus; 🇳🇴 Volda, Norway

Voss sjukehus; 🇳🇴 Voss, Norway

Helse Forde; 🇳🇴 Førde, Norway