Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2009 |
| End Date: | April 2012 |
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.
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.
We found this trial at
1
site
Children's Memorial Hospital, Chicago Ann & Robert H. Lurie Children
Click here to add this to my saved trials
