Given Indication for Gastric Bypass Procedure Clinical Trial
| Verified date | October 2010 |
| Source | Cantonal Hospital of St. Gallen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Observational |
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.
| Status | Completed |
| Enrollment | 437 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients who received a laparoscopic Roux-en-Y-gastric bypass Exclusion Criteria: - previous CCE - open gastric bypass procedure - previous bariatric procedure other than gastric banding - patients lost to follow up |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of surgery | St. Gallen |
| Lead Sponsor | Collaborator |
|---|---|
| Cantonal Hospital of St. Gallen |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | biliary complications resulting from omitted prophylactic cholecystectomy | 5 years | No | |
| Secondary | safety of concurrent cholecystectomy | 30 days | No |