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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Procedure: Sleeve gastrectomy without gastropexy; Procedure: Sleeve gastrectomy with gastropexy

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 Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Villy Vage, MD PhD; Phone Number: 47 90863744; Email: villy.vage@helse-bergen.no
• Study Contact Backup: Name: John Andersen, PhD; Phone Number: 47 48278186; Email: john.roger.andersen@helse-forde.no

Study Locations

• Norway
  • Førde, Norway
    • Helse Forde
    • Contact: Villy Våge, PhD; Phone Number: 47 90863744; Email: villy.vage@helse-bergen.no
    • Contact: John Roger Andersen, PhD; Phone Number: 47 48278186; Email: john.roger.andersen@helse-forde.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 421917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Information about Sleeve-pex will be found at the SOReg-N webpage.
• IPD Sharing Time Frame: The study protocol including analysis plan and formula for informed consent will be available at the SOReg-N webpage from the beginning of the study.
• IPD Sharing Access Criteria: The study protocol is available at SOReg-N webpage. Data from the study will be made available for other researchers on request if approved by the ethical review board.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No