Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00908193

Purpose

The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .

In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.

Condition	Intervention	Phase
Abdominal Wall Hernia	Device: Laparoscopic DA VINCI Robot Assisted coelioscopy Procedure: conventional coelioscopy	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

Resource links provided by NLM:

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Evaluate the reduction in morphine consumption [ Time Frame: during the postoperative 48h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain patient (ENS, total consumption of morphine) [ Time Frame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery ] [ Designated as safety issue: No ]
quality of life (questionary SF-36) [ Time Frame: 1 month, 6 month and 12 month of surgery ] [ Designated as safety issue: No ]
length of stay in hospital, percentage return home to 24 hours of surgery [ Time Frame: to 24 hours of surgery ] [ Designated as safety issue: No ]
morbidity [ Time Frame: during the study ] [ Designated as safety issue: No ]
resumption of work [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental robot-assisted coelioscopy	Device: Laparoscopic DA VINCI Robot Assisted coelioscopy Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
2: Active Comparator conventional coelioscopy	Procedure: conventional coelioscopy Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate

Detailed Description:

Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:

The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.

In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min).

The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.

A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).

The total duration of the study is 30 months (12 months of follow-up for each patient).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

over 18 years
with indication of hernia repair
a collar with a diameter of less than 10cm
no antecedent of hernia treatment with poses plate
agreeing coelioscopy
agreeing to participate the clinical study, having sign an informed consent
agreeing a regular monitor

Exclusion Criteria:

taking analgesic tier 2 or 3
against indication to anesthetics or coelioscopy
creatinine clearance less than 30 ml/min
pregnant woman and protected persons
no affiliation to social security
unable to understand the information form

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908193

Contacts

Contact: Claude Tayar	1 49 81 48 32 ext +33	claude.tayar@hmn.aphp.fr
Contact: Amel Gouja	1 49 81 37 52 ext +33	amel.gouja@hmn.aphp.fr

Locations

France
Groupe Hospitalier Chenevier-Mondor	Recruiting
Créteil, France, 94000
Contact: Claude Tayar 1 49 81 48 32 ext +33 claude.tayar@hmn.aphp.fr
Contact: Amel Gouja 1 49 81 37 52 ext +33 amel.gouja@hmn.aphp.fr
Principal Investigator: Claude Tayar

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Claude Tayar

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research ( Cécile JOURDAIN, project manager )
Study ID Numbers:	P051080, CRC05166
Study First Received:	May 22, 2009
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00908193 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Treatment of abdominal ruptured
Digestive system disease
Coelioscopy
Assistance robotics
Medical device
DA VINCI Robot

Pain patient
Morphine consumption
Comparative Randomized study
patient over 18 years
with ruptured abdominal
with an indication of treatment of ruptured

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on February 08, 2010