NCT05704348

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Helse Forde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
PROCEDURE	Sleeve gastrectomy with gastropexy	Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.
PROCEDURE	Sleeve gastrectomy without gastropexy	Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.

Timeline

• Start date: 2023-09-04
• Primary completion: 2027-12-01
• Completion: 2030-12-01
• First posted: 2023-01-30
• Last updated: 2024-10-30

Locations

4 sites across 1 country: Norway