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

• Sponsor: Helse Forde (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05704348
• Collaborator: (none)
• Enrollment: 550
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 94
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Procedure: Sleeve gastrectomy with gastropexy; Procedure: Sleeve gastrectomy without gastropexy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: The patient and the healtcare workers will be masked as to whether a pexi has been performed or not.
• Primary Purpose: Prevention
• Official Title: A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2027
• Anticipated Study Completion Date: Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No gastropexy Sleeve gastrectomy without gastropexy.	Procedure: Sleeve gastrectomy without gastropexy; Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.
Experimental: Gastropexy Sleeve gastrectomy with gastropexy	Procedure: Sleeve gastrectomy with gastropexy; Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.

Outcome Measures

Primary Outcome Measures

1. 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

1. Endoscopic findings [Two years]

   Visible oesophagitis according to the LA classification

2. Patient related outcome [Two years]

   GerdQ questionnaire

3. pH-metry [Two years]

   pH measurement by Bravo capsule

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helse Forde	Førde		Norway

Sponsors and Collaborators

• Helse Forde

Investigators

• Study Chair: Villy Vage, MD PhD, Helse Forde

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Villy Våge, Project leader, Helse Forde
• ClinicalTrials.gov Identifier: NCT05704348
• Other Study ID Numbers: 421917
• First Posted: Jan 30, 2023
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Jan 30, 2023