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Light Endoscopic Robot Use in Laparoscopic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00828035
First received: January 22, 2009
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

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

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical Investigation Centre - Technological Innovation  This link exits the ClinicalTrials.gov site

Publications:

Additional 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
Study First Received: January 22, 2009
Last Updated: September 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 23, 2013