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

Helse Forde

Status: Enrolling

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Sleeve gastrectomy without gastropexy; Procedure: Sleeve gastrectomy with gastropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT05704348

421917

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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550 participants in 2 patient groups

No gastropexy

Active Comparator group

Description:

Sleeve gastrectomy without gastropexy.

Treatment:

Procedure: Sleeve gastrectomy without gastropexy

Gastropexy

Experimental group

Description:

Sleeve gastrectomy with gastropexy

Treatment:

Procedure: Sleeve gastrectomy with gastropexy