EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Not Applicable

• Conditions: Gallstones

• 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

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 San Donato; 🇮🇹 Arezzo, AR, Italy

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

Ospedinale di Cisanello; 🇮🇹 Pisa, PI, Italy

Ospedale Felice Lotti; 🇮🇹 Pontedera, PI, Italy