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Light Endoscopic Robot Use in Laparoscopic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828035
First Posted: January 23, 2009
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
  Purpose

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)


Condition Intervention Phase
Laparoscopy Procedure: laparoscopic surgery Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by AdministrateurCIC, University Hospital, Grenoble:

Primary Outcome Measures:
  • Number of useful hands, robot as a useful mechanical hand [ Time Frame: one month ]

Secondary Outcome Measures:
  • To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other ) [ Time Frame: one month ]
  • 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 ]
  • Compare surgery's periods [ Time Frame: one month ]
  • Evaluate complications : Number of complications (per operative, post operative) [ Time Frame: one month ]
  • Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time [ Time Frame: one month ]
  • Medical and economic evaluation : cost benefit analysis : human cost, cost [ Time Frame: one month ]

Enrollment: 78
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1, REL
rel group : patients with light endoscopic robot
Procedure: laparoscopic surgery
comparison of two different laparoscopic surgeries : robot versus human
Other Names:
  • robotic laparoscopic surgery
  • robotic abdominal laparoscopic surgery
  • robotic urological laparoscopic surgery
Active Comparator: 2, AO
AO group : Patients with surgery assistant
Procedure: laparoscopic surgery
comparison of two different laparoscopic surgeries : robot versus human
Other Names:
  • robotic laparoscopic surgery
  • robotic abdominal laparoscopic surgery
  • robotic urological laparoscopic surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828035


Locations
France
University Hospital, Grenoble
Grenoble, Isère, France
University Hospital, Saint-Etienne
Saint-Etienne, Loire, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Christian LETOUBLON, MD University Hospital, Grenoble
Principal Investigator: Jean-Jacques RAMBEAUD, MD University Hospital, Grenoble
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00828035     History of Changes
Other Study ID Numbers: DCIC 03 39
ENDOCONTROL company
First Submitted: January 22, 2009
First Posted: January 23, 2009
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by AdministrateurCIC, University Hospital, Grenoble:
robotics
laparoscopy
surgery
computer assisted