Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

— SILS  

Official title:

Single Incision Versus Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981604
• Other study ID #: 09 07 132
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: December 12, 2011
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Need for cholecystectomy

Exclusion Criteria:

• Need for cholangiogram

Study Design

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

Related Conditions & MeSH terms

• Biliary Dyskinesia
• Cholecystolithiasis
• Cholelithiasis
• Dyskinesias
• Gallstones

Intervention

Procedure:
• SILS
Single Incision Laparoscopic Cholecystectomy
• Standard Laparoscopic Cholecystectomy
4 port technique

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Time		1 day	No
Secondary	Operative complications		2 weeks	Yes
Secondary	length of hospitalization		1 week	No
Secondary	doses of analgesics		1 week	No
Secondary	hospital/operation charges		1 week	No
Secondary	surgeon perception of difficulty		1 day	No
Secondary	cosmetic scores		6 months	No