Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00908193
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2009-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2009-05-22', 'studyFirstSubmitQcDate': '2009-05-22', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the reduction in morphine consumption', 'timeFrame': 'during the postoperative 48h'}], 'secondaryOutcomes': [{'measure': 'Pain patient (ENS, total consumption of morphine)', 'timeFrame': 'during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery'}, {'measure': 'quality of life (questionary SF-36)', 'timeFrame': '1 month, 6 month and 12 month of surgery'}, {'measure': 'length of stay in hospital, percentage return home to 24 hours of surgery', 'timeFrame': 'to 24 hours of surgery'}, {'measure': 'morbidity', 'timeFrame': 'during the study'}, {'measure': 'resumption of work', 'timeFrame': 'after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Abdominal Wall Hernia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .\n\nIn 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.', 'detailedDescription': 'Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:\n\nThe 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.\n\nIn 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).\n\nThe 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.\n\nA 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%).\n\nThe total duration of the study is 30 months (12 months of follow-up for each patient).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years\n* with indication of hernia repair\n* a collar with a diameter of less than 10cm\n* no antecedent of hernia treatment with poses plate\n* agreeing coelioscopy\n* agreeing to participate the clinical study, having sign an informed consent\n* agreeing a regular monitor\n\nExclusion Criteria:\n\n* taking analgesic tier 2 or 3\n* against indication to anesthetics or coelioscopy\n* creatinine clearance less than 30 ml/min\n* pregnant woman and protected persons\n* no affiliation to social security\n* unable to understand the information form'}, 'identificationModule': {'nctId': 'NCT00908193', 'acronym': 'ARTE', 'briefTitle': 'Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia', 'orgStudyIdInfo': {'id': 'P051080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'robot-assisted coelioscopy', 'interventionNames': ['Device: Laparoscopic DA VINCI Robot Assisted coelioscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'conventional coelioscopy', 'interventionNames': ['Procedure: conventional coelioscopy']}], 'interventions': [{'name': 'Laparoscopic DA VINCI Robot Assisted coelioscopy', 'type': 'DEVICE', 'otherNames': ['Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy'], 'description': 'Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate', 'armGroupLabels': ['1']}, {'name': 'conventional coelioscopy', 'type': 'PROCEDURE', 'description': 'Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Groupe Hospitalier Chenevier-Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Claude Tayar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}