Laparoscopy
Conditions
Keywords
robotics, laparoscopy, surgery, computer assisted
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)
Interventions
PROCEDURElaparoscopic surgery
comparison of two different laparoscopic surgeries : robot versus human
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of useful hands, robot as a useful mechanical hand | one month |
Secondary
| Measure | Time frame |
|---|---|
| Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery | one month |
| Compare surgery's periods | one month |
| To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other ) | one month |
| Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time | one month |
| Medical and economic evaluation : cost benefit analysis : human cost, cost | one month |
| Evaluate complications : Number of complications (per operative, post operative) | one month |
Countries
France
Outcome results
None listed