Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04994665 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Study acronym: Sleevepexie
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 9 sitesv7
  2. Eligibility criteria shortened, about 8 words
    • Site details revised at 1 of 9 sites
    v6
  3. Primary completion date: Nov 1, 2026 to Nov 1, 2027
    • Study sites: 6 to 9
    • Study completion date: Nov 1, 2026 to Nov 1, 2028
    v5
  4. Study sites: 4 to 6v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 1, 2026 to Nov 1, 2026
    • Start date changed from estimate of Oct 1, 2021 to Dec 7, 2021
    • Site details revised at 4 of 4 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy. This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy. Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life). The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
Trial Details
NCT Number NCT04994665
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 526 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov