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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00908193 |
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Date of registration:
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22/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
ARTE |
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Scientific title:
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Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00908193 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Claude Tayar |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Abdominal Wall Hernia
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Intervention(s)
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Device: Laparoscopic DA VINCI Robot Assisted coelioscopy
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Procedure: conventional coelioscopy
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Primary Outcome(s)
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Evaluate the reduction in morphine consumption
[Time Frame: during the postoperative 48h]
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Secondary Outcome(s)
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length of stay in hospital, percentage return home to 24 hours of surgery
[Time Frame: to 24 hours of surgery]
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morbidity
[Time Frame: during the study]
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quality of life (questionary SF-36)
[Time Frame: 1 month, 6 month and 12 month of surgery]
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Pain patient (ENS, total consumption of morphine)
[Time Frame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery]
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resumption of work
[Time Frame: after surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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