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
  Purpose

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


Condition Intervention
Biliary Dyskinesia
Gallstones
Cholecystitis
Cholelithiasis
Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
Procedure: Traditional Laparoscopic Cholecystectomy (TLC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • Cost associated with performance of the procedure and post-operative care until discharge [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195285

Locations
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)
Investigators
Principal Investigator: Kimberly M Brown, BS, MD Saint Luke's Hospital of Kansas City
  More Information

Publications:
Responsible Party: Kimberly Brown, MD, Saint Luke's Hospital
ClinicalTrials.gov Identifier: NCT01195285     History of Changes
Other Study ID Numbers: 09-423
Study First Received: September 2, 2010
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014