Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleeve gastrectomy with gastropexy, Sleeve gastrectomy without gastropexy.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
Overview
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.
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.
Primary outcome measures
- Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD [Time frame: Two years]
Secondary outcome measures (3)
- Endoscopic findings [Time frame: Two years]
- Patient related outcome [Time frame: Two years]
- pH-metry [Time frame: Two years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Norway · 4 centers
- Helse Forde — Førde
- Aleris Oslo — Oslo
- Volda sjukehus — Volda
- Voss sjukehus — Voss
Identifiers
NCT: NCT05704348 · 421917