Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-30 @ 1:09 AM
Study NCT ID:
NCT01420757
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2011-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-19', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Postoperative analgesics use', 'timeFrame': '1 week'}, {'measure': 'complications', 'timeFrame': '4 weeks'}, {'measure': 'operation time', 'timeFrame': '1 day'}, {'measure': 'length of hospital stay', 'timeFrame': '4 weeks'}, {'measure': 'recurrence', 'timeFrame': '5 years'}, {'measure': 'mortality', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['operation time', 'length of hospital stay'], 'conditions': ['Postoperative Pain', 'Complications', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.\n\nThe ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hernia diameter between 3 and 15 cm\n* location at the ventral abdominal wall at least 5cm from costae and inguinal area\n* indication for elective repair\n* age of 18 years or older\n* written informed consent.\n\nExclusion Criteria:\n\n* contraindication for pneumoperitoneum\n* an absolute contraindication for general anesthesia\n* history of open abdomen treatment\n* patients participating in other trials'}, 'identificationModule': {'nctId': 'NCT01420757', 'acronym': 'COLIBRI', 'briefTitle': 'Laparoscopic Versus Open Incisional Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'COLIBRI trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open', 'description': 'open incisional hernia repair', 'interventionNames': ['Procedure: incisional hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic', 'description': 'laparoscopic incisional hernia repair', 'interventionNames': ['Procedure: incisional hernia repair']}], 'interventions': [{'name': 'incisional hernia repair', 'type': 'PROCEDURE', 'description': 'Tension-free open or laparoscopic incisional hernia repair', 'armGroupLabels': ['laparoscopic', 'open']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'J.F. Lange, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. J.F. Lange', 'investigatorFullName': 'hasan eker', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}