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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
268
CCK using Triport
CCK using three or four ports
University Hospital of Lausanne
Lausanne, Switzerland
Pain (value on a Visual Analog Scale)
VAS
Time frame: 1 day
Pain (value on a Visual Analog Scale)
VAS
Time frame: 2 days
Pain (value on a Visual Analog Scale)
VAS
Time frame: 1 month
Pain (value on a Visual Analog Scale)
VAS
Time frame: 3 month
Pain (value on a Visual Analog Scale)
VAS
Time frame: 1 year
Complications
In euro
Time frame: 1 month
Operative time
In euro
Time frame: Operative day
Cost analysis
In euro
Time frame: 1 year
Cosmetic results
According to POSAS score
Time frame: 1 month
Cosmetic results
According to POSAS score
Time frame: 3 month
Cosmetic results
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
According to POSAS score
Time frame: 1 year
Complications
According to Clavien classification and CCI
Time frame: 3 month
Complications
According to Clavien classification and CCI
Time frame: 1 year