NCT00981604

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Single Incision Versus Laparoscopic Cholecystectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholelithiasis
• Biliary Dyskinesia

Interventions

Type	Name	Description
PROCEDURE	SILS	Single Incision Laparoscopic Cholecystectomy
PROCEDURE	Standard Laparoscopic Cholecystectomy	4 port technique

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-09-22
• Last updated: 2011-12-13

Locations

1 site across 1 country: United States