Cholecystitis Clinical Trial
Official title:
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
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 |
This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Saint Luke's Health System | Tyco Healthcare Group LP (d/b/a Covidien) |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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