Clinical trial NCT01195285: 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
Overall status: TERMINATED
Phase: NA
Conditions: Biliary Dyskinesia
Gallstones
Cholecystitis
Cholelithiasis
Keywords: Laparoscopic cholecystectomy
Quality of life
Biliary Cholic
Chronic Cholecystitis
Symptomatic Cholelithiasis
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Tyco Healthcare Group LP (d/b/a Covidien)
First posted: 2010-09-06
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cost associated with performance of the procedure and post-operative care until discharge
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain scale reported by patient at discharge, 24 and 48 hours
timeFrame: 24 hours and 48 hours
measure: Amount of pain medicine required during 48 hours after surgery
timeFrame: 48 hours
measure: Major and minor gastrointestinal surgical complications, including conversion
timeFrame: 4 weeks
measure: Quality of Life
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: St. Luke's Hospital, Kansas City, Missouri
name: Kimberly M Brown, BS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Single-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009
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.
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.