Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 9:07 AM
Study NCT ID:
NCT06154603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Gastrointestinal Perforations: a Nationwide Registry-based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-11-23', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'One year after diagnosis', 'description': 'Mortality up to one year after diagnosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical outcomes', 'General surgery', 'Upper gastrointestinal perforation'], 'conditions': ['Acute Abdomen']}, 'descriptionModule': {'briefSummary': 'The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with an upper gastrointestinal perforation between 2005-2023 in Sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of at least 18 years\n* perforation in either oesophagus, stomach or small intestine\n* treatment carried out in Sweden\n* diagnosis set between January 2005 and August 2023\n\nExclusion Criteria:\n\n* children'}, 'identificationModule': {'nctId': 'NCT06154603', 'briefTitle': 'Upper Gastrointestinal Perforations: a Nationwide Registry-based Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Risk Factors for and Survival After Oesophageal, Gastric and Small Intestinal Perforations: a National Observational Registry-based Cohort Study', 'orgStudyIdInfo': {'id': 'K 2023-7938'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oesophageal perforation', 'description': 'Adult patients (at least 18 years of age) with an oesophageal perforation, treated for it at a Swedish hospital between 2005-2023.', 'interventionNames': ['Procedure: Surgical treatment type']}, {'label': 'Gastric perforation', 'description': 'Adult patients (at least 18 years of age) with a gastric perforation, treated for it at a Swedish hospital between 2005-2023.', 'interventionNames': ['Procedure: Surgical treatment type']}, {'label': 'Small intestinal perforation', 'description': 'Adult patients (at least 18 years of age) with a small intestinal perforation, treated for it at a Swedish hospital between 2005-2023.', 'interventionNames': ['Procedure: Surgical treatment type']}], 'interventions': [{'name': 'Surgical treatment type', 'type': 'PROCEDURE', 'description': 'This observational design will study the clinical outcome for each type of upper gastrointestinal perforation in relation to surgical or non-surgery treatment and in relation to treatment centre.', 'armGroupLabels': ['Gastric perforation', 'Oesophageal perforation', 'Small intestinal perforation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Rebecka Ahl Hulme, MD, PhD', 'role': 'CONTACT', 'email': 'rebecka.ahl-hulme@regionstockholm.se', 'phone': '0046812373212'}], 'overallOfficials': [{'name': 'Rebecka Ahl Hulme, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Rebecka Ahl Hulme', 'investigatorAffiliation': 'Region Stockholm'}}}}