SILS™ Port Laparoscopic Cholecystectomy Post Market Study

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.