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
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
Treatments tested in this trial
- Sleeve gastrectomy with gastropexy
- Sleeve gastrectomy without gastropexy
Treatment groups
550 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov