Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
Study NCT ID:
NCT06718595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-12-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Management of Appendicular Abscess
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-Incidence of intraoperative complications', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendiceal Abscess']}, 'referencesModule': {'references': [{'pmid': '24293801', 'type': 'BACKGROUND', 'citation': 'Brown C, Kang L, Kim ST. Percutaneous drainage of abdominal and pelvic abscesses in children. Semin Intervent Radiol. 2012 Dec;29(4):286-94. doi: 10.1055/s-0032-1330062.'}, {'pmid': '26802841', 'type': 'BACKGROUND', 'citation': 'Darwazeh G, Cunningham SC, Kowdley GC. A Systematic Review of Perforated Appendicitis and Phlegmon: Interval Appendectomy or Wait-and-See? Am Surg. 2016 Jan;82(1):11-5.'}, {'pmid': '23840138', 'type': 'BACKGROUND', 'citation': 'Tannoury J, Abboud B. Treatment options of inflammatory appendiceal masses in adults. World J Gastroenterol. 2013 Jul 7;19(25):3942-50. doi: 10.3748/wjg.v19.i25.3942.'}, {'pmid': '24493295', 'type': 'BACKGROUND', 'citation': 'Deelder JD, Richir MC, Schoorl T, Schreurs WH. How to treat an appendiceal inflammatory mass: operatively or nonoperatively? J Gastrointest Surg. 2014 Apr;18(4):641-5. doi: 10.1007/s11605-014-2460-1. Epub 2014 Feb 4.'}, {'pmid': '26899348', 'type': 'BACKGROUND', 'citation': 'Bal A, Ozkececi ZT, Turkoglu O, Ozsoy M, Celep RB, Yilmaz S, Arikan Y. Demographic characteristics and seasonal variations of acute appendicitis. Ann Ital Chir. 2015;86:539-44.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to detect indications of surgical drainage after failure Ultrasound guided percutaneous drainage This study will include any male and female above 18 years old that presented with appendicular abscess Patients with appendicular abscess above the age of 18 years old All patients with generalized peritonitis or immunocompromised patients will be excluded from the study', 'detailedDescription': 'Prospective randomized study we will collect 30 patients diagnosed with appendicular abscess and they all will undergo Ultrasound guided percutaneous drainage of abscess and the group who will fail to insert the pigtail will undergo surgical drainage we will record the time of operation, number of cases with intraoperative complications and then follow up these patients during time of hospital stay for post operative pain and paralytic ileus\n\nStudy outcomes:\n\nPrimary outcomes:\n\n1. Incidence of intra operative complications\n2. Length of operations\n3. Post operative pain\n4. Incidence of intraoperative complications as injury of important structures\n5. Lenght of hospital stay\n6. Incidence of post operative complications related to surgery as wound infection, recurrence, intestinal obstruction\n\nSecondary outcomes:\n\n1. Cosmotic outcomes\n2. Incidence of recurrence of pathology\n3. Patient satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 100 patients was diagnosed with appendicular abscess in the emergency unit, department of general surgery, faculty of medicine, Assiut university', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with appendicular abscess above the age of 18 years old\n\nExclusion Criteria:\n\n* Generalized peritonitis and patients with signs of spreading infection, toxemia and septicemia Multi-locular appendicular abscess Immunocompromised patients, hepatic dysfunction, renal impairment, uncontrolled patients and cardiac disease'}, 'identificationModule': {'nctId': 'NCT06718595', 'briefTitle': 'Study of Management of Appendicular Abscess', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Percutaneous Drainage of Appendicular Abscess, is There Any Need for Further Open Drainage ?', 'orgStudyIdInfo': {'id': 'Appendicular abscess drainage'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Mamdouh Thabet, Doctor', 'role': 'CONTACT', 'email': 'Fadysamir380@gmail.com', 'phone': '01288910475'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'David Mamdouh Thabet', 'investigatorAffiliation': 'Assiut University'}}}}