Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
This study has been terminated.
(Investigator decisions based on slow enrollment.)
Sponsor:
Saint Luke's Health System
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
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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
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 Gallstones Cholelithiasis Cholecystolithiasis 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 May 23, 2013