Light Endoscopic Robot Use in Laparoscopic Surgery

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Completed
• CT.gov ID: NCT00828035
• Collaborator: (none)
• Enrollment: 78
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 39
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Laparoscopy	Procedure: laparoscopic surgery	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• 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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of useful hands, robot as a useful mechanical hand [one month]

Secondary Outcome Measures

1. To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other ) [one month]

2. Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery [one month]

3. Compare surgery's periods [one month]

4. Evaluate complications : Number of complications (per operative, post operative) [one month]

5. Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time [one month]

6. Medical and economic evaluation : cost benefit analysis : human cost, cost [one month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Grenoble	Grenoble	Isère	France
2	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Investigation Centre - Technological Innovation

Publications

• 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. Epub 2002 Jun 14.
• 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. Review. French.

• Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT00828035
• Other Study ID Numbers: DCIC 03 39; ENDOCONTROL company
• First Posted: Jan 23, 2009
• Last Update Posted: Sep 18, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AdministrateurCIC, principal investigator, University Hospital, Grenoble: robotics; laparoscopy; surgery; computer assisted

Study Results

No Results Posted as of Sep 18, 2012