Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
Primary Purpose
Biliary Dyskinesia, Gallstones, Cholecystitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-Incision Laparoscopic Surgery cholecystectomy
Traditional Laparoscopic Cholecystectomy (TLC)
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Dyskinesia focused on measuring Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis
Eligibility Criteria
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
Sites / Locations
- Saint Luke's Hospital of Kansas City
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single-Incision Laparoscopic Cholecsytectomy (SILS)
Traditional Laparoscopic Cholecystectomy (TLC)
Arm Description
Outcomes
Primary Outcome Measures
Cost associated with performance of the procedure and post-operative care until discharge
Secondary Outcome Measures
Pain scale reported by patient at discharge, 24 and 48 hours
Amount of pain medicine required during 48 hours after surgery
Major and minor gastrointestinal surgical complications, including conversion
Quality of Life
Full Information
NCT ID
NCT01195285
First Posted
September 2, 2010
Last Updated
April 27, 2012
Sponsor
Saint Luke's Health System
Collaborators
Tyco Healthcare Group LP (d/b/a Covidien)
1. Study Identification
Unique Protocol Identification Number
NCT01195285
Brief Title
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
Official Title
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Investigator decisions based on slow enrollment.
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Saint Luke's Health System
Collaborators
Tyco Healthcare Group LP (d/b/a Covidien)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Dyskinesia, Gallstones, Cholecystitis, Cholelithiasis
Keywords
Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Incision Laparoscopic Cholecsytectomy (SILS)
Arm Type
Active Comparator
Arm Title
Traditional Laparoscopic Cholecystectomy (TLC)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Single-Incision Laparoscopic Surgery cholecystectomy
Intervention Description
Laparoscopic Cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Traditional Laparoscopic Cholecystectomy (TLC)
Intervention Description
Laparoscopic Cholecystectomy
Primary Outcome Measure Information:
Title
Cost associated with performance of the procedure and post-operative care until discharge
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain scale reported by patient at discharge, 24 and 48 hours
Time Frame
24 hours and 48 hours
Title
Amount of pain medicine required during 48 hours after surgery
Time Frame
48 hours
Title
Major and minor gastrointestinal surgical complications, including conversion
Time Frame
4 weeks
Title
Quality of Life
Time Frame
2 weeks and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly M Brown, BS, MD
Organizational Affiliation
Saint Luke's Hospital of Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Single-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009
Results Reference
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PubMed Identifier
19412642
Citation
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.
Results Reference
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PubMed Identifier
19031097
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.
Results Reference
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Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
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