Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06834958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery done if needed', 'timeFrame': 'Days of hospital reservation', 'description': 'Patient with acute appendicitis and normal WBCS count will be under observation for while but people with evidence on imaging and high inflammatory markers will go under surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical diagnosis of acute appendicitis'], 'conditions': ['Acute Appendicitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/books/NBK493193/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis', 'detailedDescription': '2.4.1- Type of the study: prospective clinical trial study 2.4. 2- Study Setting: Assuit university hospital 2.4. 3- Study subjects:\n\n1. Inclusion criteria:\n\n patients complain of Rt iliac pain with Us positive for acute appendicitis with WBCS normal .\n2. Exclusion criteria:\n\nmalignant mass cancer appendix mesenteric adentis cecal diverticulum salpingitis c. Sample Size Calculation: 50 cases 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Lab WBCS count CRP level Neutrophil differential count Clinical correlation US findings and MSCT if needed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '14 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study not need special type of people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion\n\n* Male or female patients é clinically diagnosed acute appendicitis with normal WBCS\n\nExclusion Criteria:\n\n* complicated AA (perforation, peri appendicular abscess or suspicion of a tumor.\n\n 2\\_inflammatory bowel diseases 3\\_inability to co-operate and give informed consent 4\\_diffuse peritonitis 5\\_Patients with serious comorbid conditions DM \\& renal insufficiency, serum creatinine \\> 150 μmol/l 6\\_Pregnant \\& lactating patient 7\\_Patients with advanced malignancies \\& pt on immunosuppressive drugs'}, 'identificationModule': {'nctId': 'NCT06834958', 'briefTitle': 'Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology', 'orgStudyIdInfo': {'id': 'Clinical diagnosis of acute ap'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient included who have acute appendicitis clinically and normal WBCS count', 'interventionNames': ['Procedure: Appendectomy']}], 'interventions': [{'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Open surgery for appendix which is inflamed', 'armGroupLabels': ['Patient included who have acute appendicitis clinically and normal WBCS count']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgeon', 'investigatorFullName': 'Abdelrhman Kotb', 'investigatorAffiliation': 'Assiut University'}}}}