Overview

This trial is active, not recruiting.

Condition gallbladder disease
Treatments sils™ port laparoscopic cholecystectomy, four port laparoscopic cholecystectomy
Phase phase 4
Sponsor Covidien
Start date April 2009
End date September 2011
Trial size 200 participants
Trial identifier NCT00832767, AS08012

Summary

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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
SILS™ Port Laparoscopic Cholecystectomy
sils™ port laparoscopic cholecystectomy
This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
(Active Comparator)
Four Port Laparoscopic Cholecystectomy
four port laparoscopic cholecystectomy
This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
Principal investigator Jeffrey Marks, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Covidien.