Clinical trial NCT00828035: Light Endoscopic Robot Use in Laparoscopic Surgery
Official title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Laparoscopy
Keywords: robotics
laparoscopy
surgery
computer assisted
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: Number of useful hands, robot as a useful mechanical hand
timeFrame: one month
Secondary outcomes:
measure: To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )
timeFrame: one month
measure: Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery
timeFrame: one month
measure: Compare surgery's periods
timeFrame: one month
measure: Evaluate complications : Number of complications (per operative, post operative)
timeFrame: one month
measure: Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time
timeFrame: one month
measure: Medical and economic evaluation : cost benefit analysis : human cost, cost
timeFrame: one month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
state: Isère
city: Saint-Etienne
country: France
facility: University Hospital, Saint-Etienne
state: Loire
Study officials:
affiliation: University Hospital, Grenoble
name: Christian LETOUBLON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Jean-Jacques RAMBEAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. French.
citation: 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. doi: 10.1007/s00464-001-9174-7. Epub 2002 Jun 14.
citation: Jarry 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.