Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
- Conditions
- CholelithiasisBiliary Dyskinesia
- Registration Number
- NCT00981604
- Lead Sponsor
- Children's Mercy Hospital Kansas City
- Brief Summary
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
- Detailed Description
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Need for cholecystectomy
- Need for cholangiogram
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Operative Time 1 day
- Secondary Outcome Measures
Name Time Method Operative complications 2 weeks length of hospitalization 1 week doses of analgesics 1 week hospital/operation charges 1 week surgeon perception of difficulty 1 day cosmetic scores 6 months
Trial Locations
- Locations (1)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Children's Mercy Hospital🇺🇸Kansas City, Missouri, United States