EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Gallstones Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01709877
• Other study ID #: AOUP_1
• Secondary ID: RF-2009-1535329
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2012
• Last updated: June 28, 2013
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2013
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Franco Mosca, Prof. MD
• Phone: +39 (0)50 996820
• Email: f.mosca[@]med.unipi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallstones

Intervention

Procedure:
• Cholecystectomy
Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease

Locations

Country	Name	City	State
Italy	Ospedale San Donato	Arezzo	AR
Italy	Ospedale Campo di Marte	Lucca	LU
Italy	Ospedinale di Cisanello	Pisa	PI
Italy	Ospedale Felice Lotti	Pontedera	PI

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana	Regione Toscana, Scuola Superiore Sant'Anna di Pisa, Università di Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port	During the intervention	Yes
Primary	Morbidity	1 = if the patient has surgical complications 0 = no complications	30 days	Yes
Primary	Mortality		30 days	Yes
Secondary	Postoperative course	pain, measured using 1) visual linear analogue scale and 2) analgesic administration	1 week	No
Secondary	Duration of hospital stay	Date of the operation Date of hospital discharge	6 days	No
Secondary	Return of bowel function	Passage of flatus and/or bowel motion	12, 24, 48 hours	No