Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
- Conditions
- Cholecystolithiasis
- Interventions
- Procedure: Single Trocar CCKProcedure: Standard CCK
- Registration Number
- NCT00974194
- Lead Sponsor
- University of Lausanne Hospitals
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
- Cholecystolithiasis
- Age 18 to 75 y.o.
- BMI < 35
- Immunodeficiency
- Choledocholithiasis
- Previous upperGI open surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SinglePort CCK Single Trocar CCK CCK using Triport LS CCK Standard CCK CCK using three or four trocars
- Primary Outcome Measures
Name Time Method Pain (value on a Visual Analog Scale) 1 year VAS
- Secondary Outcome Measures
Name Time Method Complications 1 year According to Clavien classification and CCI
Cosmetic results 1 year According to POSAS score
Operative time Operative day In euro
Cost analysis 1 year In euro
Trial Locations
- Locations (1)
University Hospital of Lausanne
🇨🇭Lausanne, Switzerland