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EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Biliary Tract Diseases
Calculi
Cholecystolithiasis
Cholelithiasis
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014