LaparoscopyPhase 2/3NCT00828035
Light Endoscopic Robot Use in Laparoscopic Surgery
A Phase 2/3 study testing laparoscopic surgery in people with Laparoscopy, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment) Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopy
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2008to Apr 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic surgery indicated
- Subject with ASA Score 1, 2 or 3
- Subject with health and social protection
- 18 years of age or older
- Written Informed Consent
Who cannot join
- Subject is pregnant or lactating
- Subject in jail
- Subject hospitalizes without consent
- Protected persons aged 18 years or older
- Subject participated in another study
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Grenoble
Grenoble, Isère
University Hospital, Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region
About this study
Official title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)
Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)
- Conditions
- Laparoscopy
- Being tested
- laparoscopic surgery
- Keywords
- robotics, laparoscopy, surgery, computer assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
Also called robotic laparoscopic surgery, robotic abdominal laparoscopic surgery, robotic urological laparoscopic surgery
comparison of two different laparoscopic surgeries : robot versus human
| Study group | Role | What they receive |
|---|---|---|
| 1, REL | Other | rel group : patients with light endoscopic robot Receives: Procedure: laparoscopic surgery |
| 2, AO | Active comparator | AO group : Patients with surgery assistant Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of useful hands, robot as a useful mechanical hand
Measured: one month
Secondary outcomes (6)
To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )
Measured: one month
Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery
Measured: one month
Compare surgery's periods
Measured: one month
Evaluate complications : Number of complications (per operative, post operative)
Measured: one month
Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time
Measured: one month
Medical and economic evaluation : cost benefit analysis : human cost, cost
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LaparoscopyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Christian LETOUBLON, MD, Principal investigator, University Hospital, GrenobleJean-Jacques RAMBEAUD, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828035
- Sponsor's protocol ID
- DCIC 03 39
- Other IDs
- ENDOCONTROL company
- Status last verified
- Sep 2012
- First submitted
- 22 Jan 2009
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. French.
PubMed 16526532Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. doi: 10.1007/s00464-001-9174-7. Epub 2002 Jun 14.
PubMed 12235507Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.
PubMed 23477369
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00828035
- Acronym / sponsor ID
- DCIC 03 39
- Conditions
- Laparoscopy
- Keywords
- robotics, laparoscopy, surgery, computer assisted
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Jan 2009 (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.
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)
Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, REL | Other | Procedure: laparoscopic surgeryrel group : patients with light endoscopic robot |
| 2, AO | Active comparator | Procedure: laparoscopic surgeryAO group : Patients with surgery assistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Laparoscopic surgery indicated
- Subject with ASA Score 1, 2 or 3
- Subject with health and social protection
- 18 years of age or older
- Written Informed Consent
Key exclusion criteria (5 listed)
- Subject is pregnant or lactating
- Subject in jail
- Subject hospitalizes without consent
- Protected persons aged 18 years or older
- Subject participated in another study
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 |
|---|---|---|
| laparoscopic surgeryAlso: robotic laparoscopic surgery, robotic abdominal laparoscopic surgery, robotic urological laparoscopic surgerycomparison of two different laparoscopic surgeries : robot versus human | Procedure or surgery | 1, REL, 2, AO |
Primary outcome
Number of useful hands, robot as a useful mechanical hand
Time frame: one month
6 secondary outcomes
To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )
Time frame: one month
Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery
Time frame: one month
Compare surgery's periods
Time frame: one month
Evaluate complications : Number of complications (per operative, post operative)
Time frame: one month
Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time
Time frame: one month
Medical and economic evaluation : cost benefit analysis : human cost, cost
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Background: PubMed 16526532Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. French.
- Background: PubMed 12235507Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. doi: 10.1007/s00464-001-9174-7. Epub 2002 Jun 14.
- Derived from this study: PubMed 23477369Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.
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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.
Christian LETOUBLON, MD principal investigator
University Hospital, Grenoble
Jean-Jacques RAMBEAUD, MD principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing laparoscopic surgery in people with Laparoscopy, run by University Hospital, Grenoble at 2 sites in France.
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 5 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: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of useful hands, robot as a useful mechanical hand (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828035, which also lists 3 linked publications.
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 18 Sep 2012.