Light Endoscopic Robot Use in Laparoscopic Surgery

Phase 2

Completed

• Conditions: Laparoscopy

• Registration Number: NCT00828035
• Lead Sponsor: University Hospital, Grenoble

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-04
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Study Completion: 2011-04
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of useful hands, robot as a useful mechanical hand	one month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital, Grenoble; 🇫🇷 Grenoble, Isère, France

University Hospital, Saint-Etienne; 🇫🇷 Saint-Etienne, Loire, France