EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Sponsor

Azienda Ospedaliero, Universitaria Pisana (Other)

Overall Status

Unknown status

CT.gov ID

NCT01709877

Collaborator

Regione Toscana (Other), Scuola Superiore Sant'Anna di Pisa (Other), Università di Pisa (Other)

300

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallstones	Procedure: Cholecystectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional multiport laparoscopic cholecystectomy Standard laparoscopic cholecystectomy performed by the traditional multiport technique	Procedure: Cholecystectomy Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
Experimental: Single port laparoscopic cholecystectomy Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments	Procedure: Cholecystectomy Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

Arm

Intervention/Treatment

Active Comparator: Traditional multiport laparoscopic cholecystectomy

Standard laparoscopic cholecystectomy performed by the traditional multiport technique

Procedure: Cholecystectomy

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

Experimental: Single port laparoscopic cholecystectomy

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

Procedure: Cholecystectomy

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

Outcome Measures

Primary Outcome Measures

Conversion rate [During the intervention]
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Morbidity [30 days]
1 = if the patient has surgical complications 0 = no complications
Mortality [30 days]

Secondary Outcome Measures

Postoperative course [1 week]
pain, measured using 1) visual linear analogue scale and 2) analgesic administration
Duration of hospital stay [6 days]
Date of the operation Date of hospital discharge
Return of bowel function [12, 24, 48 hours]
Passage of flatus and/or bowel motion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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