Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

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

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.

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

Inclusion Criteria:

• Cholecystolithiasis
• Age 18 to 75 y.o.
• BMI < 35

Exclusion Criteria:

• Immunodeficiency
• Choledocholithiasis
• Previous upperGI open surgery