Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-02 @ 7:09 AM
Study NCT ID:
NCT04187235
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2015-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '3 years', 'description': 'Recurrence of parastomal hernia'}], 'secondaryOutcomes': [{'measure': 'Mesh-related morbidity', 'timeFrame': '3 years', 'description': 'Late mesh-related morbidity'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'Early postoperative complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parastomal Hernia']}, 'descriptionModule': {'briefSummary': 'This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.', 'detailedDescription': 'Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.\n\nSummary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.\n\nMethods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with parastomal hernia referred to Aarhus University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients with a diagnosis of parastomal hernia and indication for surgical treatment -\n\nExclusion Criteria: None\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04187235', 'briefTitle': 'Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.', 'orgStudyIdInfo': {'id': 'Keyhole vs Sugarbaker'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Keyhole rapair', 'description': '74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009', 'interventionNames': ['Procedure: Laparascopic repair of parastomal hernia']}, {'label': 'Sugarbaker repair', 'description': '61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015', 'interventionNames': ['Procedure: Laparascopic repair of parastomal hernia']}], 'interventions': [{'name': 'Laparascopic repair of parastomal hernia', 'type': 'PROCEDURE', 'description': 'Laparascopic repair of parastomal hernia', 'armGroupLabels': ['Keyhole rapair', 'Sugarbaker repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Paul Wara, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have no permission to share individual participant data with 3rd parties'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Vitaly Alexandrovich Gameza', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}