NCT01709877

EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Randomised Non-inferiority Trial of Laparoscopic Cholecystectomy Performed With EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach Using Clinical, PROMS and Health Economic Endpoints

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.

Conditions

• Gallstones

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy	Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2012-10-18
• Last updated: 2013-07-01

Locations

4 sites across 1 country: Italy