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Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies — SPoCOT  

Cholecystolithiasis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00974194
Study type Interventional
Source University of Lausanne Hospitals
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date September 1, 2018
View Details
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