Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-03-05 @ 3:46 AM
Study NCT ID:
NCT06550856
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-29', 'releaseDate': '2025-07-10'}], 'estimatedResultsFirstSubmitDate': '2025-07-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010439', 'term': 'Peptic Ulcer Perforation'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative follow up for repair of perforated peptic ulcer', 'timeFrame': 'Three days after the operation', 'description': 'resumption of oral intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perforated Peptic Ulcer']}, 'referencesModule': {'references': [{'pmid': '2742484', 'type': 'BACKGROUND', 'citation': 'Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017.'}, {'pmid': '3800459', 'type': 'BACKGROUND', 'citation': 'Boey J, Choi SK, Poon A, Alagaratnam TT. Risk stratification in perforated duodenal ulcers. A prospective validation of predictive factors. Ann Surg. 1987 Jan;205(1):22-6. doi: 10.1097/00000658-198701000-00005.'}, {'pmid': '28138363', 'type': 'BACKGROUND', 'citation': 'Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.'}]}, 'descriptionModule': {'briefSummary': "The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.\n\nExclusion Criteria:\n\n\\- 1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).\n\n2\\. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.'}, 'identificationModule': {'nctId': 'NCT06550856', 'briefTitle': 'SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER', 'orgStudyIdInfo': {'id': 'Soh-Med-24-07-07MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER', 'description': "Group (A ) includes modification of the Graham's patch will be used in this group, where suitable sutures are passed between the edges of perforation and tied to close the perforation. A pedicle of omentum based on right omental artery is brought between these sutures, and these sutures are tied again with pedicle of omentum between knots over the perforation (thus the omentum remains sandwiched between the two levels of secured knots).", 'interventionNames': ['Procedure: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER', 'description': "Group (B) includes Grahm's technique of omentopexy will be performed by closing the perforation by placing interrupted full thickness suitable sutures along the margins of the ulcer with a patch of pedicled omentum laid over these sutures, which are then tied (without any attempt for primary closure of the perforation before placing the omentum as a plug).", 'interventionNames': ['Procedure: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER']}], 'interventions': [{'name': 'SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER', 'type': 'PROCEDURE', 'description': 'Patients presented with perforated peptic ulcer will be repaired using full thickness suture closure using 3/0 vicryl suture then omental patch laied over the sutures.', 'armGroupLabels': ['SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER']}, {'name': 'OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER', 'type': 'PROCEDURE', 'description': 'Patients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation.', 'armGroupLabels': ['OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER']}]}, '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': 'Adel A Abdrabou, Resident', 'role': 'CONTACT', 'email': 'adelosman3399@gmail.com', 'phone': '01014910091'}, {'name': 'Asem Elsani M Ali, Professor', 'role': 'CONTACT', 'phone': '0100 2613245'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in the Department of General Surgery, oncological and Laparoscopic Surgery Sohag University Hospital', 'investigatorFullName': 'Adel Ashraf Abdrabou', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-10', 'type': 'RELEASE'}, {'date': '2025-07-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Adel Ashraf Abdrabou, Resident in the Department of General Surgery, oncological and Laparoscopic Surgery Sohag University Hospital, Sohag University'}}}}