Clinical Trial: Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Single Incision Versus Laparoscopic Cholecystectomy
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 Summary:
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.
Sponsor: Children's Mercy Hospital Kansas City
Current Primary Outcome: Operative Time [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Operative complications [ Time Frame: 2 weeks ]
- length of hospitalization [ Time Frame: 1 week ]
- doses of analgesics [ Time Frame: 1 week ]
- hospital/operation charges [ Time Frame: 1 week ]
- surgeon perception of difficulty [ Time Frame: 1 day ]
- cosmetic scores [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Children's Mercy Hospital Kansas City
Dates:
Date Received: September 21, 2009
Date Started: August 2009
Date Completion:
Last Updated: December 12, 2011
Last Verified: December 2011
