SILS™ Port Laparoscopic Cholecystectomy Post Market Study
This study is ongoing, but not recruiting participants.
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00832767
First received: January 29, 2009
Last updated: July 31, 2012
Last verified: January 2012
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Purpose
The objectives of this trial are:
- to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Gallbladder Disease |
Procedure: SILS™ port laparoscopic cholecystectomy Procedure: Four Port Laparoscopic Cholecystectomy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy |
Resource links provided by NLM:
Further study details as provided by Covidien:
Primary Outcome Measures:
- Feasibility and safety of SILS™ port cholecystectomy versus 4PLC as indicated by intraoperative and postoperative adverse events. [ Time Frame: Ten time points out to one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pain [ Time Frame: Seven time points ] [ Designated as safety issue: No ]
- Quality of life/ time to return to normal activity [ Time Frame: Six time points ] [ Designated as safety issue: No ]
- Cosmesis [ Time Frame: Five time points ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | August 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
SILS™ Port Laparoscopic Cholecystectomy
|
Procedure: SILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
|
|
Active Comparator: 2
Four Port Laparoscopic Cholecystectomy
|
Procedure: Four Port Laparoscopic Cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between 18 and 85 years old.
- Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF < 30%.
- Body Mass Index (BMI) < 45 kg/m2.
Exclusion Criteria:
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- Any patient with acute calculus or acalculous cholecystitis.
- Any patient who has had an upper midline or right sub costal incision.
- Any patient with pre-operative indication for a cholangiogram.
- Any patient with ASA > 3 with normal liver function.
- Any patient who is undergoing Peritoneal Dialysis (PD).
- Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832767
Locations
| United States, Connecticut | |
| Yale New Haven Medical Center | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33601 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New York | |
| North Shore - Long Island Jewish Health System | |
| Lake Success, New York, United States, 11042 | |
| St. Francis Hospital | |
| Roslyn, New York, United States, 11576 | |
| United States, Ohio | |
| Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-8819 | |
| Italy | |
| Catholic University of Sacred Heart | |
| Rome, Italy | |
| United Kingdom | |
| Imperial College, England, St. Mary's Hospital | |
| London, United Kingdom | |
Sponsors and Collaborators
Covidien
Investigators
| Principal Investigator: | Jeffrey Marks, MD | Case Medical Center University Hospitals |
More Information
No publications provided by Covidien
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT00832767 History of Changes |
| Other Study ID Numbers: | AS08012 |
| Study First Received: | January 29, 2009 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board Italy: National Monitoring Centre for Clinical Trials - Ministry of Health United Kingdom: Research Ethics Committee |
Keywords provided by Covidien:
|
Laparoscopic Cholecystectomy Single Incision Laparoscopic Surgery Surgical Procedures, Minimally Invasive |
Additional relevant MeSH terms:
|
Gallbladder Diseases Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013