RecruitingNot ApplicableNCT05704348

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


Sponsor

Helse Forde

Enrollment

550 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients planned for bariatric surgery with primary LSG

Exclusion Criteria4

  • 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

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Interventions

PROCEDURESleeve gastrectomy with gastropexy

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

PROCEDURESleeve gastrectomy without gastropexy

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


Locations(4)

Helse Forde

Førde, Norway

Aleris Oslo

Oslo, Norway

Volda sjukehus

Volda, Norway

Voss sjukehus

Voss, Norway

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NCT05704348


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