Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05704348

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

Led by Helse Forde · Updated on 2024-10-30

550

Participants Needed

4

Research Sites

377 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients planned for bariatric surgery with primary laparoscopic sleeve gastrectomy (LSG)
Not Eligible

You will not qualify if you...

  • Age below 18 years
  • Use of acid-reducing medication for reasons other than reflux
  • Previous antireflux surgery
  • Inability to understand and respond to patient-reported outcome questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Helse Forde

Førde, Norway

Not Yet Recruiting

2

Aleris Oslo

Oslo, Norway

Actively Recruiting

3

Volda sjukehus

Volda, Norway

Actively Recruiting

4

Voss sjukehus

Voss, Norway

Actively Recruiting

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Research Team

V

Villy Vage, MD PhD

CONTACT

J

John Andersen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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