Cholelithiasis Clinical Trial
— SILSOfficial title:
Single Incision Versus Laparoscopic Cholecystectomy
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 18 Years |
Eligibility |
Inclusion Criteria: - Need for cholecystectomy Exclusion Criteria: - Need for cholangiogram |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative Time | 1 day | No | |
Secondary | Operative complications | 2 weeks | Yes | |
Secondary | length of hospitalization | 1 week | No | |
Secondary | doses of analgesics | 1 week | No | |
Secondary | hospital/operation charges | 1 week | No | |
Secondary | surgeon perception of difficulty | 1 day | No | |
Secondary | cosmetic scores | 6 months | No |
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