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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy — SILS  

Cholelithiasis Clinical Trial

Official title:
Single Incision Versus Laparoscopic Cholecystectomy

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00981604
Study type Interventional
Source Children's Mercy Hospital Kansas City
Contact
Status Completed
Phase N/A
Start date August 2009
Completion date August 2011
View Details
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