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NCT04324515
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
NA trial testing Robotic gastric bypass with or without cholecystectomy in Roux-en-Y Gastric Bypass in 90 participants. Status unknown.
1 August 2020
Quick facts
| Lead sponsor | University of Geneva, Switzerland |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 90 |
| Start date | 18 July 2018 |
| Primary completion | 1 August 2020 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Robotic gastric bypass with or without cholecystectomy
Conditions studied
- Roux-en-Y Gastric Bypass — all drugs for Roux-en-Y Gastric Bypass →
- Cholecystitis; Gallstone — all drugs for Cholecystitis; Gallstone →
- Gallbladder Diseases — all drugs for Gallbladder Diseases →
Sponsor
University of Geneva, Switzerland
Who can join
18 and older, any sex, with Roux-en-Y Gastric Bypass or Cholecystitis; Gallstone. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04324515
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04324515 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Geneva, Switzerland
- Last refreshed: 27 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04324515.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing