Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT04176432
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2019-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival After Emergency Laparotomy in Octogenarians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Deaths within 30 days after emergency laparotomy', 'timeFrame': 'From date of emergency laparotomy until 30 days after surgery', 'description': 'Mortality at 30 days after date of emergency laparotomy'}], 'secondaryOutcomes': [{'measure': 'Number of Deaths within 90 days after emergency laparotomy', 'timeFrame': '90 days after emergency laparotomy', 'description': 'Mortality at 90 days after date of emergency laparotomy'}, {'measure': 'Number of Deaths within 1 year after emergency laparotomy', 'timeFrame': '1 year after emergency laparotomy', 'description': 'Mortality at 1 year after date of emergency laparotomy'}, {'measure': 'Postoperative complications', 'timeFrame': 'Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.', 'description': 'Number of patients having a postoperative complication as defined by the European Perioperative Clinical Outcome Definitions (EPCO) will be reported. The EPCO definitions state universal description of various common postoperative complications, like f.ex pulmonary complications, major adverse cardiac events, urinary tract infections and so on. This is a way of securing a universal approach to postoperative complications.\n\nWe will grade complications according to the Clavien Dindo classification. According to this classification postoperative complications are graded from 1 to 5, where 1 indicates least severity of complication and 5 indicating worst severity. We will report number of patients having complications from grade 2 to grade 5.'}, {'measure': 'Level of care at discharge', 'timeFrame': 'Up to 90 days from date of emergency laparotomy.', 'description': 'From the medical records will be retreived information regarding dependency in activities of daily living (ADL) at discharge. Specifically will be measured number of patients discharged to own home, and number of patients discharged to nursing home facility. Also will be measured number of patients transferred to other hospital.'}]}, 'conditionsModule': {'keywords': ['Emergency surgery', 'Frailty', 'Elderly', 'Postoperative complications'], 'conditions': ['Abdomen, Acute', 'Surgery--Complications', 'Postoperative Complications', 'Frailty']}, 'descriptionModule': {'briefSummary': 'In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.', 'detailedDescription': 'Methods:\n\nDuring 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.\n\nPrimary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.\n\nThe Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Haukeland University Hospital during 2015-2016', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* emergency laparotomy in patients 80 years or above\n\nExclusion Criteria:\n\n* palliative surgery\n* abdominal surgery other than gastrointestinal\n* abdominal surgery without midline incision'}, 'identificationModule': {'nctId': 'NCT04176432', 'briefTitle': 'Survival After Emergency Laparotomy in Octogenarians', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older', 'orgStudyIdInfo': {'id': '2017/610'}, 'secondaryIdInfos': [{'id': 'REK 9526', 'type': 'OTHER', 'domain': 'Regional Ethics Committe'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Retrospective observational study with no intervention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}