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DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass

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

Record History

  1. Notable Primary completion date: May 2025 to Sep 2029
    • Study completion date: May 2027 to Dec 2029
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Study sites: 7 to 8v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2021 to May 1, 2021
    • Site details revised at 7 of 7 sites
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Trial Details
NCT Number NCT04894838
Lead Sponsor St. Antonius Hospital
Collaborators: Medtronic
Conditions
(from sponsor)
Obesity, Morbid, Weight Gain
Related terms Obesity, Obesity, Morbid, Weight Gain
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov