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

NCT05704348 | Recruiting DMC

• 1 other identifier: 421917
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Endoscopic findings

  Two years

• Patient related outcome

  Two years

• pH-metry

  Two years

Study Arms (2)

No gastropexy

ACTIVE COMPARATOR

Sleeve gastrectomy without gastropexy.

Procedure: Sleeve gastrectomy without gastropexy

Gastropexy

EXPERIMENTAL

Sleeve gastrectomy with gastropexy

Procedure: Sleeve gastrectomy with gastropexy

Interventions

Sleeve gastrectomy with gastropexy PROCEDURE

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

Gastropexy

Sleeve gastrectomy without gastropexy PROCEDURE

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

No gastropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for bariatric surgery with primary LSG

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Forde: lead

Study Sites (4)

Helse Forde

Førde, Norway

NOT YET RECRUITING

Aleris Oslo

Oslo, Norway

RECRUITING

Volda sjukehus

Volda, Norway

RECRUITING

Voss sjukehus

Voss, Norway

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Gastropexy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Villy Vage, MD PhD

  Helse Forde

  STUDY CHAIR

Central Study Contacts

Villy Vage, MD PhD

CONTACT

47 90863744; villy.vage@helse-bergen.no

John Andersen, PhD

CONTACT

47 48278186; john.roger.andersen@helse-forde.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patient and the healtcare workers will be masked as to whether a pexi has been performed or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 30, 2023
• Study Start: September 4, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

NO (4)