Light Endoscopic Robot Use in Laparoscopic Surgery

Study Overview
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Brief Summary
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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)

Official Title
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Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

Conditions
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Laparoscopy

Intervention / Treatment
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* Procedure: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1, REL<br>rel group : patients with light endoscopic robot | Procedure: laparoscopic surgery<br>* comparison of two different laparoscopic surgeries : robot versus human<br>* Other names: robotic urological laparoscopic surgery;|
| Active Comparator: 2, AO<br>AO group : Patients with surgery assistant | Procedure: laparoscopic surgery<br>* comparison of two different laparoscopic surgeries : robot versus human<br>* Other names: robotic urological laparoscopic surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of useful hands, robot as a useful mechanical hand |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other ) |  | one month | 
| 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 | 
| Evaluate complications : Number of complications (per operative, post operative) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotics, laparoscopy, surgery, computer assisted