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EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

NCT01709877 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-07-01

No results posted yet for this study

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

PROCEDURE

Cholecystectomy

Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

Sponsors & Collaborators

  • Regione Toscana

    collaborator UNKNOWN

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Università di Pisa

    collaborator UNKNOWN

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • Franco Mosca, Prof, MD · AOUP

  • Alfred Cuschieri, Prof, MD · Scuola Superiore Sant'Anna di Pisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-07-31
Completion
2014-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709877 on ClinicalTrials.gov