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EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Franco Mosca, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709877
First Posted: October 18, 2012
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Regione Toscana
Scuola Superiore Sant'Anna di Pisa
Università di Pisa
Information provided by (Responsible Party):
Franco Mosca, Azienda Ospedaliero, Universitaria Pisana
  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
Intervention Model: Parallel Assignment
Masking: None (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 Franco Mosca, Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • Conversion rate [ Time Frame: 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 [ Time Frame: 30 days ]
    1 = if the patient has surgical complications 0 = no complications

  • Mortality [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Postoperative course [ Time Frame: 1 week ]
    pain, measured using 1) visual linear analogue scale and 2) analgesic administration

  • Duration of hospital stay [ Time Frame: 6 days ]
    Date of the operation Date of hospital discharge

  • Return of bowel function [ Time Frame: 12, 24, 48 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 di Pisa
Università di Pisa
Investigators
Principal Investigator: Franco Mosca, Prof, MD AOUP
Principal Investigator: Alfred Cuschieri, Prof, MD Scuola Superiore Sant'Anna di Pisa
  More Information

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 ( Other Identifier: Ministero della Salute - Direzione Generale della Ricerca Scientifica e Tecnologica; Regione Toscana )
First Submitted: October 17, 2012
First Posted: October 18, 2012
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by Franco Mosca, 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