Health TrialsbyHealthPanel

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

ConditionGastroesophageal Reflux
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelse Forde

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients planned for bariatric surgery with primary LSG

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleeve gastrectomy with gastropexy

    Procedure/Surgery

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

  • Sleeve gastrectomy without gastropexy

    Procedure/Surgery

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

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: No gastropexyActive comparator 1 intervention
Group B: GastropexyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

ARM: Daily use of ARM for the last month

Time frame
Two years

Secondary outcomes

1

Endoscopic findings

Visible oesophagitis according to the LA classification

Time frame
Two years
2

Patient related outcome

GerdQ questionnaire

Time frame
Two years
3

pH-metry

pH measurement by Bravo capsule

Time frame
Two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helse Forde

Lead sponsor

Source ClinicalTrials.gov
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