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

Primary Purpose

Gastroesophageal Reflux

Status

Not yet recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Sleeve gastrectomy with gastropexy

Sleeve gastrectomy without gastropexy

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Helse Forde

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No gastropexy

Gastropexy

Arm Description

Sleeve gastrectomy without gastropexy.

Sleeve gastrectomy with gastropexy

Outcomes

Primary Outcome Measures

Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD

ARM: Daily use of ARM for the last month

Secondary Outcome Measures

Endoscopic findings

Visible oesophagitis according to the LA classification

Patient related outcome

GerdQ questionnaire

pH-metry

pH measurement by Bravo capsule

Full Information

NCT ID

NCT05704348

First Posted

January 10, 2023

Last Updated

January 19, 2023

Sponsor

Helse Forde

1. Study Identification

Unique Protocol Identification Number

NCT05704348

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2023 (Anticipated)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helse Forde

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

The patient and the healtcare workers will be masked as to whether a pexi has been performed or not.

Allocation

Randomized

Enrollment

550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No gastropexy

Arm Type

Active Comparator

Arm Description

Sleeve gastrectomy without gastropexy.

Arm Title

Gastropexy

Arm Type

Experimental

Arm Description

Sleeve gastrectomy with gastropexy

Intervention Type

Procedure

Intervention Name(s)

Sleeve gastrectomy with gastropexy

Intervention Description

Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.

Intervention Type

Procedure

Intervention Name(s)

Sleeve gastrectomy without gastropexy

Intervention Description

Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.

Primary Outcome Measure Information:

Title

Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD

Description

ARM: Daily use of ARM for the last month

Time Frame

Two years

Secondary Outcome Measure Information:

Title

Endoscopic findings

Description

Visible oesophagitis according to the LA classification

Time Frame

Two years

Title

Patient related outcome

Description

GerdQ questionnaire

Time Frame

Two years

Title

pH-metry

Description

pH measurement by Bravo capsule

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Villy Vage, MD PhD

Phone

47 90863744

villy.vage@helse-bergen.no

First Name & Middle Initial & Last Name or Official Title & Degree

John Andersen, PhD

Phone

47 48278186

john.roger.andersen@helse-forde.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Villy Vage, MD PhD

Organizational Affiliation

Helse Forde

Official's Role

Study Chair

Facility Information:

Facility Name

Helse Forde

City

Førde

Country

Norway

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Villy Våge, PhD

Phone

47 90863744

villy.vage@helse-bergen.no

First Name & Middle Initial & Last Name & Degree

John Roger Andersen, PhD

Phone

47 48278186

john.roger.andersen@helse-forde.no

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://helse-bergen.no/avdelinger/laboratorieklinikken/medisinsk-biokjemi-og-farmakologi/norsk-kvalitetsregister-for-fedmekirurgi-soreg-norge

Learn more about this trial

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

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