EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Azienda Ospedaliero, Universitaria Pisana

Status: Unknown

Conditions: Gallstones

Treatments: Procedure: Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01709877

RF-2009-1535329 (Other Identifier)

AOUP_1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Traditional multiport laparoscopic cholecystectomy

Active Comparator group

Description:

Standard laparoscopic cholecystectomy performed by the traditional multiport technique

Treatment:

Procedure: Cholecystectomy

Single port laparoscopic cholecystectomy

Experimental group

Description:

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

Treatment:

Procedure: Cholecystectomy