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

Gastroesophageal Reflux Clinical Trial

Official title:

A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05704348
• Other study ID #: 421917
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2030

Study information

• Verified date: January 2023
• Source: Helse Forde
• Contact: Villy Vage, MD PhD
• Phone: 47 90863744
• Email: villy.vage[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: December 2030
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Sleeve gastrectomy with gastropexy
Gastropexy in this project means suturing the gastric remnant to the gastrocolic ligament.
• Sleeve gastrectomy without gastropexy
Sleeve gastrectomy without suturing the gastric remnant to the gastrocolic ligament.

Locations

Country	Name	City	State
Norway	Helse Forde	Førde

Sponsors (1)

Lead Sponsor	Collaborator
Helse Forde

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD	ARM: Daily use of ARM for the last month	Two years
Secondary	Endoscopic findings	Visible oesophagitis according to the LA classification	Two years
Secondary	Patient related outcome	GerdQ questionnaire	Two years
Secondary	pH-metry	pH measurement by Bravo capsule	Two years