Light Endoscopic Robot Use in Laparoscopic Surgery

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Laparoscopy

Treatments: Procedure: laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00828035

ENDOCONTROL company

DCIC 03 39

Details and patient eligibility

About

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)

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

1, REL

Other group

Description:

rel group : patients with light endoscopic robot

Treatment:

Procedure: laparoscopic surgery

2, AO

Active Comparator group

Description:

AO group : Patients with surgery assistant

Treatment:

Procedure: laparoscopic surgery