Traditional laparoscopic cholecystectomy versus SILS™ port laparoscopic cholecystectomy

Completed

• Conditions: Acute calculus, acalculous cholecystitis; Surgery

• Registration Number: ISRCTN74919832
• Lead Sponsor: Covidien Surgical Devices (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Both males and females, between 18 and 65 years old
2. The patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or biliary dyskinesia with documented ejection fraction (EF) <30%
3. Body mass index (BMI) <35 kg/m^2
4. The patient or patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site
5. The patient agrees to return to the same research facility for all study-required post-procedure follow-up visits

Exclusion Criteria

1. Any female patient who is pregnant, suspected pregnant, or nursing
2. Any patient with acute calculus or acalculous cholecystitis
3. Any patient who has had an upper midline or right sub costal incision
4. Any patient with pre-operative indication for a cholangiogram
5. Any patient with American Society of Anesthesiologists (ASA) >3 with normal liver function
6. Any patient who is undergoing peritoneal dialysis (PD)
7. Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair

Study & Design

• Study Type: Interventional
• Study Design: Not specified