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

NCT05704348 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2024-10-30

No results posted yet for this study

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

Interventions

PROCEDURE

Sleeve gastrectomy with gastropexy

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

PROCEDURE

Sleeve gastrectomy without gastropexy

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

Sponsors & Collaborators

  • Helse Forde

    lead OTHER

Principal Investigators

  • Villy Vage, MD PhD · Helse Forde

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05704348 on ClinicalTrials.gov