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Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

This study has been terminated.
(Investigator decisions based on slow enrollment.)
Sponsor:
Collaborator:
Tyco Healthcare Group LP (d/b/a Covidien)
Information provided by:
Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT01195285
First received: September 2, 2010
Last updated: April 27, 2012
Last verified: August 2011
History of Changes

September 2, 2010
April 27, 2012
February 2010
January 2012   (final data collection date for primary outcome measure)
Cost associated with performance of the procedure and post-operative care until discharge [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01195285 on ClinicalTrials.gov Archive Site
  • Pain scale reported by patient at discharge, 24 and 48 hours [ Time Frame: 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Amount of pain medicine required during 48 hours after surgery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Major and minor gastrointestinal surgical complications, including conversion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Biliary Dyskinesia
  • Gallstones
  • Cholecystitis
  • Cholelithiasis
  • Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
    Laparoscopic Cholecystectomy
  • Procedure: Traditional Laparoscopic Cholecystectomy (TLC)
    Laparoscopic Cholecystectomy
  • Active Comparator: Single-Incision Laparoscopic Cholecsytectomy (SILS)
    Intervention: Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
  • Active Comparator: Traditional Laparoscopic Cholecystectomy (TLC)
    Intervention: Procedure: Traditional Laparoscopic Cholecystectomy (TLC)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01195285
09-423
No
Kimberly Brown, MD, Saint Luke's Hospital
Saint Luke's Health System
Tyco Healthcare Group LP (d/b/a Covidien)
Principal Investigator: Kimberly M Brown, BS, MD Saint Luke's Hospital of Kansas City
Saint Luke's Health System
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP