EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Not Applicable

• Conditions: Gallstones
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT01709877
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-18
• Study Start: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01
• Primary Completion: 2014-07
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional multiport laparoscopic cholecystectomy	Cholecystectomy	Standard laparoscopic cholecystectomy performed by the traditional multiport technique
Single port laparoscopic cholecystectomy	Cholecystectomy	Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Ospedale Campo di Marte; 🇮🇹 Lucca, LU, Italy

Ospedale San Donato; 🇮🇹 Arezzo, AR, Italy

Ospedinale di Cisanello; 🇮🇹 Pisa, PI, Italy

Ospedale Felice Lotti; 🇮🇹 Pontedera, PI, Italy