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SILS™ Port Laparoscopic Cholecystectomy Post Market Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Medtronic - MITG.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832767
First Posted: January 30, 2009
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Medtronic - MITG
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy

Further study details as provided by Medtronic - MITG:

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 ]

Secondary Outcome Measures:
  • Pain [ Time Frame: Seven time points ]
  • Quality of life/ time to return to normal activity [ Time Frame: Six time points ]
  • Cosmesis [ Time Frame: Five time points ]

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

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Medtronic - MITG
Investigators
Principal Investigator: Jeffrey Marks, MD Case Medical Center University Hospitals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00832767     History of Changes
Other Study ID Numbers: AS08012
First Submitted: January 29, 2009
First Posted: January 30, 2009
Last Update Posted: October 12, 2017
Last Verified: January 2012

Keywords provided by Medtronic - MITG:
Laparoscopic Cholecystectomy
Single Incision Laparoscopic Surgery
Surgical Procedures, Minimally Invasive

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases