SILS™ Port Laparoscopic Cholecystectomy Post Market Study
NCT ID: NCT00832767
Last Updated: 2017-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2009-04-30
2012-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SILS Port
SILS™ Port Laparoscopic Cholecystectomy
SILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
Four Port
Four Port Laparoscopic Cholecystectomy
Four Port Laparoscopic Cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Interventions
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SILS™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
Four Port Laparoscopic Cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Marks, MD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center University Hospitals
Locations
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Yale New Haven Medical Center
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
North Shore - Long Island Jewish Health System
Lake Success, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Case Medical Center
Cleveland, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Catholic University of Sacred Heart
Rome, , Italy
Imperial College, England, St. Mary's Hospital
London, , United Kingdom
Countries
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References
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Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012 Oct;26(10):2823-7. doi: 10.1007/s00464-012-2253-0. Epub 2012 May 2.
Other Identifiers
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AS08012
Identifier Type: -
Identifier Source: org_study_id