Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-10 @ 8:22 AM
Study NCT ID:
NCT04791657
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2021-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Elderly Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-07', 'studyFirstSubmitDate': '2021-03-07', 'studyFirstSubmitQcDate': '2021-03-07', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day postoperative complication rate', 'timeFrame': '30 days', 'description': 'The primary clinical outcome of interest is 30-day postoperative complications. The Clavien-Dindo classification will be used to grade postoperative outcomes and complications'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality rate', 'timeFrame': '30 days', 'description': 'In-hospital mortality is defined as death occurring during the hospital stay after the surgical procedure'}, {'measure': '30-day readmission rate', 'timeFrame': '30 days', 'description': '30-day readmission is defined as unplanned readmission to the hospital within 30 days of discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['appendicitis', 'geriatrics'], 'conditions': ['Appendicitis Acute']}, 'referencesModule': {'references': [{'pmid': '32865733', 'type': 'BACKGROUND', 'citation': 'Angeramo CA, Dreifuss NH, Giacone J, Schlottmann F. Outcomes of Acute Appendicitis in Elderly Patients: a Single Center Analysis of 2000 Laparoscopic Appendectomies. J Gastrointest Surg. 2020 Dec;24(12):2859-2861. doi: 10.1007/s11605-020-04726-z. Epub 2020 Aug 31. No abstract available.'}, {'pmid': '28708770', 'type': 'BACKGROUND', 'citation': 'Yang J, Yu K, Li W, Si X, Zhang J, Wu W, Cao Y. Laparoscopic Appendectomy for Complicated Acute Appendicitis in the Elderly: A Single-center Experience. Surg Laparosc Endosc Percutan Tech. 2017 Oct;27(5):366-368. doi: 10.1097/SLE.0000000000000447.'}, {'pmid': '12215147', 'type': 'BACKGROUND', 'citation': 'Hui TT, Major KM, Avital I, Hiatt JR, Margulies DR. Outcome of elderly patients with appendicitis: effect of computed tomography and laparoscopy. Arch Surg. 2002 Sep;137(9):995-8; discussion 999-1000. doi: 10.1001/archsurg.137.9.995.'}, {'pmid': '23016482', 'type': 'BACKGROUND', 'citation': 'Pokharel N, Sapkota P, Kc B, Rimal S, Thapa S, Shakya R. Acute appendicitis in elderly patients: a challenge for surgeons. Nepal Med Coll J. 2011 Dec;13(4):285-8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.', 'detailedDescription': 'Appendicitis in elderly patients is more challenging due to delayed presentation and higher comorbidities, which is associated with increased postoperative morbidity and mortality. In this study, we aim to investigate the factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients. Records of patients who underwent appendectomy for appendicitis will be extracted. The primary outcome is 30-day postoperative complications. Independent variables examined include demographics, comorbidities, preoperative laboratory values, pathological findings, and surgical features. Both univariate and multivariate regression will be performed to identify factors associated with postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged 65 years and older undergoing appendectomy for acute appendicitis are included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years and older\n* Patients undergoing appendectomy for acute appendicitis (pathologically confirmed)\n* Patients having complete records of clinical data and postoperative follow-up records\n\nExclusion Criteria:\n\n* Patients younger than 65 years\n* Patients undergoing an appendectomy as part of another major operation or those with appendiceal malignancy\n* Patients who are treated nonoperatively for acute appendicitis'}, 'identificationModule': {'nctId': 'NCT04791657', 'briefTitle': 'Outcome of Elderly Patients With Appendicitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gulhane Training and Research Hospital'}, 'officialTitle': 'Factors Associated With Postoperative Complications After the Surgical Treatment of Appendicitis in Elderly Patients', 'orgStudyIdInfo': {'id': 'Gulhane2021-51'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without complications', 'description': 'Patients with uneventful recovery', 'interventionNames': ['Procedure: Appendectomy']}, {'label': 'Patients with complications', 'description': 'Patients experiencing complications within 30 days postoperatively', 'interventionNames': ['Procedure: Appendectomy']}], 'interventions': [{'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Surgical treatment for appendicitis', 'armGroupLabels': ['Patients with complications', 'Patients without complications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Suleyman U Celik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulhane Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suleyman Utku Celik', 'investigatorAffiliation': 'Gulhane Training and Research Hospital'}}}}