Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT06042933
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of days of hospital stay', 'timeFrame': 'Up to 10 days', 'description': 'number of days of hospital stay'}, {'measure': 'days needed for frist Bowel motion', 'timeFrame': '7 days', 'description': 'number of days before frist bowel motion'}], 'secondaryOutcomes': [{'measure': 'incidence of Post operative repair leak', 'timeFrame': '30 days', 'description': 'number of Post operative repair leaks'}, {'measure': 'severity of operative pain measured by Visual Analogue Scale (VAS)', 'timeFrame': '7 days', 'description': 'from 1 to 10 1 indicated minimum pain and 10 maximum pain'}, {'measure': 'INCIDENCE OF postoperative nausea and vomiting (PONAV)', 'timeFrame': '7 days', 'description': 'number of cases with postoperative nausea and vomiting (PONAV)'}, {'measure': 'incidence of Surgical site infection', 'timeFrame': '30 days', 'description': 'number of cases complicated with surgical site infection'}, {'measure': 'incidence of Pulmonary complications', 'timeFrame': '30 days', 'description': 'number of cases complicated Pulmonary complications'}, {'measure': 'incidence of Ryle reinsertion', 'timeFrame': '7 days', 'description': 'number of cases complicated Ryle reinsertion'}, {'measure': 'number of Readmission cases', 'timeFrame': '30 days', 'description': 'number of cases complicated Readmission cases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peptic Ulcer Perforation']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population \\& Sample size :(', 'detailedDescription': 'Study Design:\n\nThis study is a single-center, prospective, parallel arm, randomized controlled trial. Patients will be randomly assigned in 1:1 ratio to receive either delayed oral feeding or early oral feeding.\n\nMethods:\n\nPatients will be randomly assigned into two groups. Group A patients followed an early oral feeding protocol(12 hours), and Group B received delayed oral feeding (72 hours).\n\nOutcome parameter :\n\nThe outcomes are incidence of postoperative complications including Postoperative repair leakage, Infection-related postoperative complications , Number of days of hospital stay and return of bowel function and Diet intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All consecutive patients, of age 18 years and above, who were\n\npresented to the emergency surgical team and were diagnosed with perforated duodenal ulcer by surgicalteam, were recruited and assessed for eligibility.\n\nExclusion Criteria:\n\n* • Preoperative refractory septic shock on admission.\n\n * Delayed presentation more than 24 hours.\n * The presence of neuropsychiatric disease, pregnant and lactating women.\n * Predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV.\n * American society of anesthesiologists grade iii/iv, or had an alternative perioperative diagnosis.\n * Intraoperatively, after randomization, patients were excluded based on the following criteria: perforated duodenal ulcer ≥20 mm, consistent with malignant ulcers.'}, 'identificationModule': {'nctId': 'NCT06042933', 'briefTitle': 'Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center', 'orgStudyIdInfo': {'id': 'N-96-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'early oral intake 6 hours postoperative.', 'interventionNames': ['Other: Post operative early oral feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'delayed oral intake after 72 hours', 'interventionNames': ['Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs']}], 'interventions': [{'name': 'Post operative early oral feeding', 'type': 'OTHER', 'description': 'To start oral feeding 6 hours after perforated peptic ulcer repairs', 'armGroupLabels': ['Group A']}, {'name': 'Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs', 'type': 'OTHER', 'description': 'To start oral feeding after 48 hours', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mohammed elshwadfy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of general surgery', 'investigatorFullName': 'Mohammed Elshwadfy Nageeb', 'investigatorAffiliation': 'Cairo University'}}}}