Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01195285
• Other study ID #: 09-423
• Status: Terminated
• Phase: N/A
• First received: September 2, 2010
• Last updated: April 27, 2012
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2011
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Description:

Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient recommended to undergo cholecystectomy

• Patient age 18-80

• Patient competent to give his/her own informed consent

• Patient speaks English without the need for an interpreter

Exclusion Criteria:

• Additional procedures planned during same surgery

• Patient deemed inappropriate for TLC or SILS cholecystectomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Dyskinesia
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Dyskinesias
• Gallstones

Intervention

Procedure:
• Single-Incision Laparoscopic Surgery cholecystectomy
Laparoscopic Cholecystectomy
• Traditional Laparoscopic Cholecystectomy (TLC)
Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Tyco Healthcare Group LP (d/b/a Covidien)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009 Sep;13(9):1733-40. doi: 10.1007/s11605-009-0902-y. Epub 2009 May 2. Review. — View Citation

Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009 Feb;13(2):188-92. doi: 10.1007/s11605-008-0735-0. Epub 2008 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost associated with performance of the procedure and post-operative care until discharge		4 weeks	No
Secondary	Pain scale reported by patient at discharge, 24 and 48 hours		24 hours and 48 hours	No
Secondary	Amount of pain medicine required during 48 hours after surgery		48 hours	No
Secondary	Major and minor gastrointestinal surgical complications, including conversion		4 weeks	No
Secondary	Quality of Life		2 weeks and 4 weeks	No