Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT06558760
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in the Treatment of Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31988}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in surgical techniques over time', 'timeFrame': '2010-2022', 'description': 'Development of the use of surgical techniques (open, laparoscopic or conversion from open to laparoscopic)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Appendicitis', 'Type of appendectomy'], 'conditions': ['Acute Appendicitis']}, 'referencesModule': {'references': [{'pmid': '40533760', 'type': 'DERIVED', 'citation': 'Schildberg C, Weber U, Konig V, Linnartz M, Heisler S, Hafkesbrink J, Fricke M, Mantke R. Laparoscopic appendectomy as the gold standard: What role remains for open surgery, conversion, and disease severity? : An analysis of 32,000 cases with appendicitis in Germany. World J Emerg Surg. 2025 Jun 18;20(1):53. doi: 10.1186/s13017-025-00626-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.', 'detailedDescription': 'This retrospective observational study analyzed routine data provided by the CLINOTEL Hospital Association Germany, covering the years 2010 to 2022. The data was derived from anonymized billing data according to the German Diagnosis-Related Groups (DRG) system for inpatient hospital treatments.\n\nThe study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy.\n\nPatients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to Intensive Care Unit, length of stay, and in-hospital-mortality. Cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. Furthermore, all cases with multiple appendectomy codes were removed from the sample. Ultimately, 31988 patients were included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute appendicitis in 68 hospitals in Germany collected by routine data between 2010 and 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Appendicitis\n\nExclusion Criteria:\n\n* Age under 18 years\n* No appendectomy performed'}, 'identificationModule': {'nctId': 'NCT06558760', 'acronym': 'TreatApp', 'briefTitle': 'Changes in the Treatment of Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Medizinische Hochschule Brandenburg Theodor Fontane'}, 'officialTitle': 'Continuous Decline in Open Appendectomies to 0.9% and Conversions to 2%', 'orgStudyIdInfo': {'id': 'TreatApp'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data is not available for data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medizinische Hochschule Brandenburg Theodor Fontane', 'class': 'OTHER'}, 'collaborators': [{'name': 'CLINOTEL Hospital Association Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Habil Claus Schildberg', 'investigatorAffiliation': 'Medizinische Hochschule Brandenburg Theodor Fontane'}}}}