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NCT00828035 Clinical Trial

Light Endoscopic Robot Use in Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:
Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00828035
Other study ID # DCIC 03 39
Secondary ID ENDOCONTROL comp
Status Completed
Phase Phase 2/Phase 3
First received January 22, 2009
Last updated September 17, 2012
Start date April 2008
Est. completion date April 2011

Study information
Verified date September 2012
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical 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)

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date April 2011
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Subject is pregnant or lactating

- Subject in jail

- Subject hospitalizes without consent

- Protected persons aged 18 years or older

- Subject participated in another study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic surgery
comparison of two different laparoscopic surgeries : robot versus human

Locations
Country Name City State
France University Hospital, Grenoble Grenoble Isère
France University Hospital, Saint-Etienne Saint-Etienne Loire

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Aiono 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. Epub 2002 Jun 14. — View Citation

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. Review. French. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of useful hands, robot as a useful mechanical hand one month Yes
Secondary To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other ) one month Yes
Secondary Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery one month Yes
Secondary Compare surgery's periods one month Yes
Secondary Evaluate complications : Number of complications (per operative, post operative) one month Yes
Secondary Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time one month Yes
Secondary Medical and economic evaluation : cost benefit analysis : human cost, cost one month Yes
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