Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-29 @ 12:56 AM
Study NCT ID:
NCT05528692
Status:
WITHDRAWN
Last Update Posted:
2025-12-05
First Post:
2022-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Collaboration stopped', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.', 'timeFrame': '2 years'}, {'measure': 'Change in quality of life, physical functioning, clinical investigation and pain-score at 1 month, 3 months, 6 months and 2 years after laparotomy.', 'timeFrame': '2 years'}, {'measure': 'Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.', 'timeFrame': '2 years'}, {'measure': '30-day, 90-day, and 1-year mortality.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incisional Hernia', 'Emergency Midline Laparotomy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.', 'detailedDescription': 'All patients operated with an emergency midline laparotomy in our clinic are potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.\n\nData will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.\n\nEnrolled patients will be followed for two years. The trial involves four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient operated with an emergency midline laparotomy in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the listed inclusion and exclusion criteria.\n\nWe aim to enroll 100 patients to ensure that 50 patients fulfill the study protocol. This is based on a risk of incisional hernia development of at least 30% over two years among the included high-risk participants, a two-year mortality of the participants as a group of 30% and a 20% loss to follow-up amongst the survivors.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding or any emergency re-operation to elective surgery\n* Age of 18 years or above\n* BMI above 27\n* At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI \\> 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age \\> 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone\n\nExclusion Criteria:\n\n* Malign, incurable disease\n* Other reasons for short life expectancy \\<2 year as evaluated by the investigator\n* Midline-incisions \\<15 cm\n* Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall\n* Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation\n* Metallic magnetic implants that serves as a contraindication for MRI-scan (including pacemakers, large tattoos, insulin pumps, etc.)\n* Metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the MRI-scan of the abdominal wall"}, 'identificationModule': {'nctId': 'NCT05528692', 'acronym': 'MAGELA', 'briefTitle': 'The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients: a Danish Prospective Single-center, Non-randomized, Non-interventional, Observational Study', 'orgStudyIdInfo': {'id': 'HerlevH2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic resonance imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI is a non-invasive imaging modality capable of producing precise soft-tissue images in all body areas. In contrast to CT scanning, MRI does not rely on ionizing radiation. There are no known risks associated with MRI as long as patients with contraindications such as pacemakers are identified and excluded. The MRI scans in this study will be performed without use of contrast media.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Gastrointestinal- and Hepatic diseases, Surgical Section,', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'All results, both positive, negative and inconclusive, will be attempted to be published in international English journals with external reviewers. Alternatively, the results will be published in another way.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Madeline Kvist', 'investigatorAffiliation': 'Herlev Hospital'}}}}