SILS™ Port Laparoscopic Cholecystectomy Post Market Study
This trial is active, not recruiting.
|Treatments||sils™ port laparoscopic cholecystectomy, four port laparoscopic cholecystectomy|
|Start date||April 2009|
|End date||September 2011|
|Trial size||200 participants|
|Trial identifier||NCT00832767, AS08012|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New Haven, CT||Yale New Haven Medical Center||no longer recruiting|
|Tampa, FL||Tampa General Hospital||no longer recruiting|
|Chicago, IL||Northwestern Memorial Hospital||no longer recruiting|
|Boston, MA||Tufts Medical Center||no longer recruiting|
|Lake Success, NY||North Shore - Long Island Jewish Health System||no longer recruiting|
|Roslyn, NY||St. Francis Hospital||no longer recruiting|
|Cleveland, OH||Case Medical Center||no longer recruiting|
|Dallas, TX||UT Southwestern Medical Center||no longer recruiting|
|Rome, Italy||Catholic University of Sacred Heart||no longer recruiting|
|London, United Kingdom||Imperial College, England, St. Mary's Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
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
time frame: Seven time points
Quality of life/ time to return to normal activity
time frame: Six time points
time frame: Five time points
Male or female participants from 18 years up to 85 years old.
- 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.
- 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.
|Official title||Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy|
|Principal investigator||Jeffrey Marks, MD|
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