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NCT Number: NCT05704348

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helse Forde, Førde, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy with gastropexy

Procedure

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

Sleeve gastrectomy without gastropexy

Procedure

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

Primary outcomes

  1. Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD

    Time frame: Two years

    ARM: Daily use of ARM for the last month

Secondary outcomes

  1. Endoscopic findings

    Time frame: Two years

    Visible oesophagitis according to the LA classification

  2. Patient related outcome

    Time frame: Two years

    GerdQ questionnaire

  3. pH-metry

    Time frame: Two years

    pH measurement by Bravo capsule

Study contacts

Contact information is provided by the study sponsor or research team.

John Andersen, PhD

CONTACT

[email protected]

47 48278186

Villy Vage, MD PhD

CONTACT

[email protected]

47 90863744

Sponsors and collaborators

Lead sponsor

Helse Forde

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jan 30, 2023
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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