SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 85
Updated:	12/20/2017
Start Date:	April 2009
End Date:	January 2012

Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy

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.

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.

We found this trial at

sites

Tampa General Hospital

1 Tampa General Cir
Tampa, Florida 33606

(813) 844-7000