EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
This study is not yet open for participant recruitment.
Verified October 2012 by Azienda Ospedaliero, Universitaria Pisana
Sponsor:
Azienda Ospedaliero, Universitaria Pisana
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: NA
Last verified: October 2012
History: No changes posted
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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: | October 2012 |
| 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 | |
| Arezzo, AR, Italy | |
| Ospedale Campo di Marte | |
| Lucca, LU, Italy | |
| Ospedinale di Cisanello | Not yet recruiting |
| Pisa, PI, Italy, 56100 | |
| Contact: Luca Morelli, MD +39 (0)50 996820 llmorelli74@hotmail.com | |
| Ospedale Felice Lotti | |
| Pontedera, PI, Italy | |
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: | October 17, 2012 |
| 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 May 21, 2013