SILS™ Port Laparoscopic Cholecystectomy Post Market Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Covidien.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00832767
First received: January 29, 2009
Last updated: July 31, 2012
Last verified: January 2012
  Purpose

The objectives of this trial are:

  1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
  2. 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
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: 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 October 23, 2014