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OpenTrials
Completed

NCT Number: NCT00828035

Light Endoscopic Robot Use in Laparoscopic Surgery

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)

Completed

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Key information

Conditions

Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital, Grenoble, Grenoble, Isère, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

comparison of two different laparoscopic surgeries : robot versus human

Other names: robotic laparoscopic surgery, robotic abdominal laparoscopic surgery, robotic urological laparoscopic surgery

Primary outcomes

  1. Number of useful hands, robot as a useful mechanical hand

    Time frame: one month

Secondary outcomes

  1. To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )

    Time frame: one month

  2. Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery

    Time frame: one month

  3. Compare surgery's periods

    Time frame: one month

  4. Evaluate complications : Number of complications (per operative, post operative)

    Time frame: one month

  5. Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time

    Time frame: one month

  6. Medical and economic evaluation : cost benefit analysis : human cost, cost

    Time frame: one month

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

Important dates

Study start
2008
Primary completion
2008
Study completion
2011
First posted
Jan 23, 2009
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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