Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT03846661
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2019-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Register study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-17', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-operation for recurrence rate', 'timeFrame': 'up to 84 months'}], 'secondaryOutcomes': [{'measure': '30-day readmission rate', 'timeFrame': '30 day'}, {'measure': '30-reoperation for complication rate', 'timeFrame': '30 day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hernia, Abdominal', 'Recurrence', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.', 'detailedDescription': 'All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.\n\nTo obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.\n\nPatients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).\n\nPhysiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect\n\nThe primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.\n\nThe secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair\n\nExclusion Criteria:\n\n* If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database'}, 'identificationModule': {'nctId': 'NCT03846661', 'briefTitle': 'Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair', 'orgStudyIdInfo': {'id': 'FH115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiomesh', 'description': 'Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.', 'interventionNames': ['Device: Physiomesh']}, {'type': 'NO_INTERVENTION', 'label': 'other mesh', 'description': 'Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.'}], 'interventions': [{'name': 'Physiomesh', 'type': 'DEVICE', 'otherNames': ['other mesh'], 'description': 'difference in risk for recurrence and postoperative complication', 'armGroupLabels': ['Physiomesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Dept. of surgery, Zealand University Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Frederik Helgstrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. Surgery, Zealand university Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frederik Helgstrand', 'investigatorAffiliation': 'Zealand University Hospital'}}}}