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Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195285
Recruitment Status : Terminated (Investigator decisions based on slow enrollment.)
First Posted : September 6, 2010
Last Update Posted : April 30, 2012
Tyco Healthcare Group LP (d/b/a Covidien)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Biliary Dyskinesia Gallstones Cholecystitis Cholelithiasis Procedure: Single-Incision Laparoscopic Surgery cholecystectomy Procedure: Traditional Laparoscopic Cholecystectomy (TLC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Single-Incision Laparoscopic Cholecsytectomy (SILS) Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
Laparoscopic Cholecystectomy

Active Comparator: Traditional Laparoscopic Cholecystectomy (TLC) Procedure: Traditional Laparoscopic Cholecystectomy (TLC)
Laparoscopic Cholecystectomy

Primary Outcome Measures :
  1. Cost associated with performance of the procedure and post-operative care until discharge [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pain scale reported by patient at discharge, 24 and 48 hours [ Time Frame: 24 hours and 48 hours ]
  2. Amount of pain medicine required during 48 hours after surgery [ Time Frame: 48 hours ]
  3. Major and minor gastrointestinal surgical complications, including conversion [ Time Frame: 4 weeks ]
  4. Quality of Life [ Time Frame: 2 weeks and 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01195285

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United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Tyco Healthcare Group LP (d/b/a Covidien)
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Principal Investigator: Kimberly M Brown, BS, MD Saint Luke's Hospital of Kansas City

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Responsible Party: Kimberly Brown, MD, Saint Luke's Hospital Identifier: NCT01195285     History of Changes
Other Study ID Numbers: 09-423
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: August 2011

Keywords provided by Saint Luke's Health System:
Laparoscopic cholecystectomy
Quality of life
Biliary Cholic
Chronic Cholecystitis
Symptomatic Cholelithiasis

Additional relevant MeSH terms:
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Acalculous Cholecystitis
Biliary Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases