EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Gallstones

Clinical Trial Details

NCT number	NCT01709877
Study type	Interventional
Source	Azienda Ospedaliero, Universitaria Pisana
Contact	Franco Mosca, Prof. MD
Phone	+39 (0)50 996820
Email	f.mosca@med.unipi.it
Status	Recruiting
Phase	N/A
Start date	April 2013
Completion date	November 2014

View Details

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