Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Not Applicable

Terminated

• Conditions: Biliary Dyskinesia; Gallstones; Cholecystitis; Cholelithiasis
• Interventions: Procedure: Single-Incision Laparoscopic Surgery cholecystectomy; Procedure: Traditional Laparoscopic Cholecystectomy (TLC)

• Registration Number: NCT01195285
• Lead Sponsor: Saint Luke's Health System

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Status Verified: 2011-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-Incision Laparoscopic Cholecsytectomy (SILS)	Single-Incision Laparoscopic Surgery cholecystectomy	-
Traditional Laparoscopic Cholecystectomy (TLC)	Traditional Laparoscopic Cholecystectomy (TLC)	-

Primary Outcome Measures

Name	Time	Method
Cost associated with performance of the procedure and post-operative care until discharge	4 weeks

Secondary Outcome Measures

Name	Time	Method
Pain scale reported by patient at discharge, 24 and 48 hours	24 hours and 48 hours
Amount of pain medicine required during 48 hours after surgery	48 hours
Major and minor gastrointestinal surgical complications, including conversion	4 weeks
Quality of Life	2 weeks and 4 weeks

Trial Locations

Locations (1)

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States