Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-31 @ 8:31 AM
Study NCT ID:
NCT07115303
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results of Laparoscopic Appendectomy With Application of Clips Versus Ligature for Stump Closure
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': 'D008026', 'term': 'Ligation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of Laparoscopic Appendectomy with application of clips versus ligature for stump closure', 'timeFrame': '24 hours postoperative', 'description': 'postoperative hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '32802324', 'type': 'BACKGROUND', 'citation': 'Makaram N, Knight SR, Ibrahim A, Patil P, Wilson MSJ. Closure of the appendiceal stump in laparoscopic appendectomy: A systematic review of the literature. Ann Med Surg (Lond). 2020 Aug 4;57:228-235. doi: 10.1016/j.amsu.2020.07.058. eCollection 2020 Sep.'}, {'pmid': '38764557', 'type': 'BACKGROUND', 'citation': 'Farahani PK, Safaei N. Comparison of two methods: Clipping and suturing in laparoscopic appendectomy. Surg Open Sci. 2024 May 3;19:162-165. doi: 10.1016/j.sopen.2024.04.007. eCollection 2024 Jun.'}, {'pmid': '37811063', 'type': 'BACKGROUND', 'citation': 'Poon SHT, Law SY, Lai ATY. Clips closure versus endoloop ligation in laparoscopic appendectomy: a systematic review and meta-analysis of comparative studies. Ann Med Surg (Lond). 2023 Sep 6;85(10):5011-5021. doi: 10.1097/MS9.0000000000001260. eCollection 2023 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This a prospective study to compare between clipping and ligation of appendicular stump in laparoscopic appendectomies regarding ;technical feasibility , post operative complications as fecal fistula and economic consideration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any patient diagnosed with acute appendicitis of any age and of any sex presented to ER of the Department of General, Laparoscopic and Oncologic Surgery Department, Sohag University Hospital will be enrolled in this study.\n\nExclusion Criteria:\n\n* Patients with complicated appendicitis.\n* Patients with unstable cardiac or pulmonary condition.\n* Patients with suspicious crhon's disease or mass intraoperative."}, 'identificationModule': {'nctId': 'NCT07115303', 'briefTitle': 'Results of Laparoscopic Appendectomy With Application of Clips Versus Ligature for Stump Closure', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Results of Laparoscopic Appendectomy With Application of Clips Versus Ligature for Stump Closure: A Comparative Study', 'orgStudyIdInfo': {'id': 'Soh-Med-25-7---18MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Appendectomy with application of clips for stump closure', 'interventionNames': ['Procedure: Laparoscopic Appendectomy with application of clips for stump closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Appendectomy with ligature for stump closure', 'interventionNames': ['Procedure: Laparoscopic Appendectomy with ligature for stump closure']}], 'interventions': [{'name': 'Laparoscopic Appendectomy with application of clips for stump closure', 'type': 'PROCEDURE', 'description': 'in patients who will undergo Laparoscopic Appendectomy, appendicular stump will be closed by application of clips', 'armGroupLabels': ['Laparoscopic Appendectomy with application of clips for stump closure']}, {'name': 'Laparoscopic Appendectomy with ligature for stump closure', 'type': 'PROCEDURE', 'description': 'in patients who will undergo Laparoscopic Appendectomy, appendicular stump will be closed by ligation', 'armGroupLabels': ['Laparoscopic Appendectomy with ligature for stump closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Ahmed A Abdelreheem, Resident', 'role': 'CONTACT', 'email': 'ahmeddd_amerrr@yahoo.com', 'phone': '01026675749'}, {'name': 'Mohamed M Ali, Professor', 'role': 'CONTACT', 'phone': '01004564240'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of General, Oncologic& Laparscopic Surgery Faculty of Medicine, Sohag University', 'investigatorFullName': 'Ahmed Amer Abdelraheem', 'investigatorAffiliation': 'Sohag University'}}}}