EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

NCT ID: NCT01709877

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional multiport laparoscopic cholecystectomy

Standard laparoscopic cholecystectomy performed by the traditional multiport technique

Group Type: ACTIVE_COMPARATOR

Cholecystectomy

Intervention Type: PROCEDURE

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

Single port laparoscopic cholecystectomy

Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments

Group Type: EXPERIMENTAL

Cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

Cholecystectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with symptomatic gallstone disease
• ASA I/II
• Age between 18 and 80 years

Exclusion Criteria

• ASA III or more
• significant co-morbid cardiovascular, neurological diseases, diabetics and chronic obstructive airway disease
• patients with previous history of invasive cancer
• patients with previous surgery
• patients requiring urgent/emergency interventions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regione Toscana

UNKNOWN

Sponsor Role: collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Università di Pisa

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Franco Mosca

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Mosca, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

AOUP

Alfred Cuschieri, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Scuola Superiore Sant'Anna di Pisa

Locations

Ospedale San Donato

Arezzo, AR, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Campo di Marte

Lucca, LU, Italy

Site Status: NOT_YET_RECRUITING

Ospedinale di Cisanello

Pisa, PI, Italy

Site Status: RECRUITING

Ospedale Felice Lotti

Pontedera, PI, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Franco Mosca, Prof. MD

Role: CONTACT

f.mosca@med.unipi.it

+39 (0)50 996820

Giovanni Caprili, MD

Role: CONTACT

mabcap@libero.it

+39 3286875111

Facility Contacts

Fabio Sbrana, MD

Role: primary

Andrea Carobbi, MD

Role: primary

Luca Morelli, MD

Role: primary

llmorelli74@hotmail.com

+39 (0)50 996820

Orlando Goletti, MD

Role: primary

Other Identifiers

RF-2009-1535329

Identifier Type: OTHER

Identifier Source: secondary_id

AOUP_1

Identifier Type: -

Identifier Source: org_study_id