NCT00974194

Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Detailed description

Design: * Prospective Randomized Controlled trial * Population analysis based on Intention To Treat * Patient and data analyzer blinded (double-blind trial) Outcomes observed: * Primary: pain * Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption Nbr of patients included: 260 Port used: Triport, Olympus

Conditions

• Cholecystolithiasis

Interventions

Type	Name	Description
PROCEDURE	Single Trocar CCK	CCK using Triport
PROCEDURE	Standard CCK	CCK using three or four ports

Timeline

• Start date: 2009-09-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2009-09-10
• Last updated: 2018-10-17

Locations

1 site across 1 country: Switzerland