Light Endoscopic Robot Use in Laparoscopic Surgery

September 17, 2012 updated by: AdministrateurCIC, University Hospital, Grenoble

Light Endoscopic Robot Use in Abdominal and Urological 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France
        • University Hospital, Grenoble
    • Loire
      • Saint-Etienne, Loire, France
        • University Hospital, Saint-Étienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Christian LETOUBLON, MD, University Hospital, Grenoble
  • Principal Investigator: Jean-Jacques RAMBEAUD, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCIC 03 39
  • ENDOCONTROL company

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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