Gastroesophageal Reflux
Conditions
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.
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
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.
Sponsors
Helse Forde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The patient and the healtcare workers will be masked as to whether a pexi has been performed or not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD | Two years | ARM: Daily use of ARM for the last month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic findings | Two years | Visible oesophagitis according to the LA classification |
| Patient related outcome | Two years | GerdQ questionnaire |
| pH-metry | Two years | pH measurement by Bravo capsule |
Countries
Norway
Contacts
Primary ContactVilly Vage, MD PhD
Backup ContactJohn Andersen, PhD
Outcome results
None listed