GallstonesNCT01709877
EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
A study testing Cholecystectomy in people with Gallstones, run by Azienda Ospedaliero, Universitaria Pisana at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallstones
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesItaly
- Study dates
- Apr 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic gallstone disease
- ASA I/II
- Age between 18 and 80 years
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Not yet recruiting
Ospedale San Donato
Arezzo, AR
Fabio Sbrana, MD
- Not yet recruiting
Ospedale Campo di Marte
Lucca, LU
Andrea Carobbi, MD
- Recruiting
Ospedinale di Cisanello
Pisa, PI, 56100
Luca Morelli, MD, +39 (0)50 996820, llmorelli74@hotmail.com
- Not yet recruiting
Ospedale Felice Lotti
Pontedera, PI
Orlando Goletti, MD
About this study
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
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.
- Conditions
- Gallstones
- Being tested
- Cholecystectomy
- Keywords
- Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
| Study group | Role | What they receive |
|---|---|---|
| Traditional multiport laparoscopic cholecystectomy | Active comparator | Standard laparoscopic cholecystectomy performed by the traditional multiport technique Receives: Procedure: Cholecystectomy |
| Single port laparoscopic cholecystectomy | Experimental | Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Measured: During the intervention
Morbidity
1 = if the patient has surgical complications 0 = no complications
Measured: 30 days
Mortality
Measured: 30 days
Secondary outcomes (3)
Postoperative course
pain, measured using 1) visual linear analogue scale and 2) analgesic administration
Measured: 1 week
Duration of hospital stay
Date of the operation Date of hospital discharge
Measured: 6 days
Return of bowel function
Passage of flatus and/or bowel motion
Measured: 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Toscana, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Università di Pisa
- Responsible party
- Principal investigator, Franco Mosca, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Franco Mosca, Prof, MD, Principal investigator, AOUPAlfred Cuschieri, Prof, MD, Principal investigator, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709877
- Sponsor's protocol ID
- AOUP_1
- Other IDs
- RF-2009-1535329
- Status last verified
- Jun 2013
- First submitted
- 17 Oct 2012
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01709877
- Acronym / sponsor ID
- AOUP_1
- Conditions
- Gallstones
- Keywords
- Multiport laparoscopy, Single Port Laparoscopy, Symptomatic Gallstones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- Regione Toscana, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Università di Pisa
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional multiport laparoscopic cholecystectomy | Active comparator | Procedure: CholecystectomyStandard laparoscopic cholecystectomy performed by the traditional multiport technique |
| Single port laparoscopic cholecystectomy | Experimental | Procedure: CholecystectomyLaparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic gallstone disease
- ASA I/II
- Age between 18 and 80 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecystectomyMultiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease | Procedure or surgery | Single port laparoscopic cholecystectomy, Traditional multiport laparoscopic cholecystectomy |
Primary outcome
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
3 secondary outcomes
Postoperative course
Time frame: 1 week
Duration of hospital stay
Time frame: 6 days
Return of bowel function
Time frame: 12, 24, 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Timing of CHolecystectomy In Severe PAncreatitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Mosca, Prof, MD principal investigator
AOUP
Alfred Cuschieri, Prof, MD principal investigator
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy in people with Gallstones, run by Azienda Ospedaliero, Universitaria Pisana at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Mosca, Prof. MD (+39 (0)50 996820, f.mosca@med.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: During the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.