Light Endoscopic Robot Use in Laparoscopic Surgery

NCT ID: NCT00828035

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Laparoscopy

Keywords

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robotics laparoscopy surgery computer assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, REL

rel group : patients with light endoscopic robot

Group Type OTHER

laparoscopic surgery

Intervention Type PROCEDURE

comparison of two different laparoscopic surgeries : robot versus human

2, AO

AO group : Patients with surgery assistant

Group Type ACTIVE_COMPARATOR

laparoscopic surgery

Intervention Type PROCEDURE

comparison of two different laparoscopic surgeries : robot versus human

Interventions

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laparoscopic surgery

comparison of two different laparoscopic surgeries : robot versus human

Intervention Type PROCEDURE

Other Intervention Names

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robotic laparoscopic surgery robotic abdominal laparoscopic surgery robotic urological laparoscopic surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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AdministrateurCIC

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian LETOUBLON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Jean-Jacques RAMBEAUD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital, Grenoble

Grenoble, Isère, France

Site Status

University Hospital, Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

Site Status

Countries

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France

References

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Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. French.

Reference Type BACKGROUND
PMID: 16526532 (View on PubMed)

Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. doi: 10.1007/s00464-001-9174-7. Epub 2002 Jun 14.

Reference Type BACKGROUND
PMID: 12235507 (View on PubMed)

Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.

Reference Type DERIVED
PMID: 23477369 (View on PubMed)

Other Identifiers

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ENDOCONTROL company

Identifier Type: -

Identifier Source: secondary_id

DCIC 03 39

Identifier Type: -

Identifier Source: org_study_id