Cholecystolithiasis
Conditions
Keywords
Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port
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
Interventions
PROCEDURESingle Trocar CCK
CCK using Triport
PROCEDUREStandard CCK
CCK using three or four ports
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Cholecystolithiasis * Age 18 to 75 y.o. * BMI \< 35
Exclusion criteria
* Immunodeficiency * Choledocholithiasis * Previous upperGI open surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (value on a Visual Analog Scale) | 1 day | VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 month | In euro |
| Operative time | Operative day | In euro |
| Cost analysis | 1 year | In euro |
| Cosmetic results | 1 month | According to POSAS score |
Countries
Switzerland
Outcome results
None listed