EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

This study is currently recruiting participants.
Verified June 2013 by Azienda Ospedaliero, Universitaria Pisana
Sponsor:
Collaborators:
Regione Toscana
Scuola Superiore Sant'Anna
Università di Pisa
Information provided by (Responsible Party):
Franco Mosca, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01709877
First received: October 17, 2012
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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 Intervention
Gallstones
Procedure: Cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • Conversion rate [ Time Frame: During the intervention ] [ Designated as safety issue: Yes ]
    1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port

  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    1 = if the patient has surgical complications 0 = no complications

  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative course [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    pain, measured using 1) visual linear analogue scale and 2) analgesic administration

  • Duration of hospital stay [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Date of the operation Date of hospital discharge

  • Return of bowel function [ Time Frame: 12, 24, 48 hours ] [ Designated as safety issue: No ]
    Passage of flatus and/or bowel motion


Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709877

Contacts
Contact: Franco Mosca, Prof. MD +39 (0)50 996820 f.mosca@med.unipi.it
Contact: Giovanni Caprili, MD +39 3286875111 mabcap@libero.it

Locations
Italy
Ospedale San Donato Not yet recruiting
Arezzo, AR, Italy
Contact: Fabio Sbrana, MD         
Ospedale Campo di Marte Not yet recruiting
Lucca, LU, Italy
Contact: Andrea Carobbi, MD         
Ospedinale di Cisanello Recruiting
Pisa, PI, Italy, 56100
Contact: Luca Morelli, MD    +39 (0)50 996820    llmorelli74@hotmail.com   
Ospedale Felice Lotti Not yet recruiting
Pontedera, PI, Italy
Contact: Orlando Goletti, MD         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Regione Toscana
Scuola Superiore Sant'Anna
Università di Pisa
Investigators
Principal Investigator: Franco Mosca, Prof, MD AOUP
Principal Investigator: Alfred Cuschieri, Prof, MD Scuola Superiore Sant'Anna
  More Information

No publications provided

Responsible Party: Franco Mosca, Prof., Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT01709877     History of Changes
Other Study ID Numbers: AOUP_1, RF-2009-1535329
Study First Received: October 17, 2012
Last Updated: June 28, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
Multiport laparoscopy
Single Port Laparoscopy
Symptomatic Gallstones

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 22, 2014