Back to resultsEndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
Primary Purpose
Gallstones
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gallstones focused on measuring Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones
Eligibility 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
Sites / Locations
- Ospedale San Donato
- Ospedale Campo di Marte
- Ospedinale di CisanelloRecruiting
- Ospedale Felice Lotti
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional multiport laparoscopic cholecystectomy
Single port laparoscopic cholecystectomy
Arm Description
Standard laparoscopic cholecystectomy performed by the traditional multiport technique
Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments
Outcomes
Primary Outcome Measures
Conversion rate
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Morbidity
1 = if the patient has surgical complications 0 = no complications
Mortality
Secondary Outcome Measures
Postoperative course
pain, measured using 1) visual linear analogue scale and 2) analgesic administration
Duration of hospital stay
Date of the operation Date of hospital discharge
Return of bowel function
Passage of flatus and/or bowel motion
Full Information
NCT ID
NCT01709877
First Posted
October 17, 2012
Last Updated
June 28, 2013
Sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborators
Regione Toscana, Scuola Superiore Sant'Anna di Pisa, Università di Pisa
1. Study Identification
Unique Protocol Identification Number
NCT01709877
Brief Title
EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborators
Regione Toscana, Scuola Superiore Sant'Anna di Pisa, Università di Pisa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones
Keywords
Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional multiport laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Standard laparoscopic cholecystectomy performed by the traditional multiport technique
Arm Title
Single port laparoscopic cholecystectomy
Arm Type
Experimental
Arm Description
Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy
Intervention Description
Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
Primary Outcome Measure Information:
Title
Conversion rate
Description
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Time Frame
During the intervention
Title
Morbidity
Description
1 = if the patient has surgical complications 0 = no complications
Time Frame
30 days
Title
Mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Postoperative course
Description
pain, measured using 1) visual linear analogue scale and 2) analgesic administration
Time Frame
1 week
Title
Duration of hospital stay
Description
Date of the operation Date of hospital discharge
Time Frame
6 days
Title
Return of bowel function
Description
Passage of flatus and/or bowel motion
Time Frame
12, 24, 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franco Mosca, Prof. MD
Phone
+39 (0)50 996820
Email
f.mosca@med.unipi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Caprili, MD
Phone
+39 3286875111
Email
mabcap@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Mosca, Prof, MD
Organizational Affiliation
AOUP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfred Cuschieri, Prof, MD
Organizational Affiliation
Scuola Superiore Sant'Anna di Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Donato
City
Arezzo
State/Province
AR
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Sbrana, MD
Facility Name
Ospedale Campo di Marte
City
Lucca
State/Province
LU
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Carobbi, MD
Facility Name
Ospedinale di Cisanello
City
Pisa
State/Province
PI
ZIP/Postal Code
56100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Morelli, MD
Phone
+39 (0)50 996820
Email
llmorelli74@hotmail.com
Facility Name
Ospedale Felice Lotti
City
Pontedera
State/Province
PI
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orlando Goletti, MD
12. IPD Sharing Statement
Learn more about this trial
EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
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