Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06570018
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal functional recovery (first bowel movement)', 'timeFrame': 'Within the first 24 hours postoperative or more', 'description': 'Tool; Patient assessment sheet\n\n* It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first bowel movement) through physical examination.\n* The mean score of time for two groups was compared'}, {'measure': 'Gastrointestinal functional recovery(first flatus passage)', 'timeFrame': 'Within the first 24 hours postoperative or more', 'description': 'Tool; Patient assessment sheet\n\n* It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first flatus passage) through physical examination.\n\nthe mean score of time for two groups was compared'}, {'measure': 'Gastrointestinal functional recovery(first stool passage)', 'timeFrame': 'First stool passage within three days postoperative or more', 'description': 'Tool; Patient assessment sheet\n\n\\- It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first stool passage) postoperative.through health history.\n\nThe mean score of time for two groups was compared'}, {'measure': 'postoperative complications', 'timeFrame': 'Immediately post operative up to thirty days postoperative', 'description': 'post operative complications included complications that occured within 30- days post operative. Every patient had been assessed for developing pneumonia, admission to critical care, abdominal collection, intra-abdominal abscess, suture leakage, omental patch leakage, septic shock, prolonged ileus, surgical site infection, urinary tract infection, deep venous thrombosis (DVT), and reoperation'}, {'measure': 'Legnth of hospital stay', 'timeFrame': 'seven days up to two weeks', 'description': 'Hospitalization duration from admission up to discharge Mean score of days for two groups will be compared.'}], 'secondaryOutcomes': [{'measure': 'gastrointestinal quality of life', 'timeFrame': 'Before hospital dicharge and after thirty days postoperative', 'description': "gastrointestinal quality of life was evaluated for all patients before discharge and after thirty days postoperative using Gastrointestinal quality of life index (Eypasch, 1993).\n\nIt is a 36-item scale divided into five domains; GIT symptoms (10 items), physical (6 items), emotion (6 items), social (2 items) and disease specific (8 items) Cronbach's alpha was 0.89\n\nScoring:\n\nEach item is based on a 0-4 Likert scale with 0 being least desirable to 4 being the most desirable option. The total scores represent Gastrointestinal Quality of Life Index. It ranges from 0 to 144 with higher scores indicating a better quality of life"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergent Surgery', 'Perforated Peptic Ulcer']}, 'referencesModule': {'references': [{'pmid': '40186297', 'type': 'DERIVED', 'citation': 'Desoky AA, Ayoub MT, Mostafa NM, Hashem EM, Mohammed MA. Short-term outcome following postoperative enhanced recovery implementation in patients with perforated peptic ulcer. Eur J Med Res. 2025 Apr 4;30(1):234. doi: 10.1186/s40001-025-02432-7.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome.\n\nThe current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.', 'detailedDescription': 'This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.\n\nMethods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.\n\nA purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.\n\npatient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ranged from 18 to 65 years,\n* Diagnosed with perforated peptic ulcer,\n* Ulcer size less than 10 mm.\n* Underwent emergent surgical intervention\n\nExclusion Criteria:\n\n* Malignant ulcer.\n* Other GIT diseases (corn's disease \\& ulcerative colitis)\n* Pregnant women\n* Psychiatric or neurological illness.\n* Who refused to participate in the study"}, 'identificationModule': {'nctId': 'NCT06570018', 'briefTitle': 'Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer', 'orgStudyIdInfo': {'id': 'Enhanced recovery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced recovery group', 'description': 'who received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer', 'interventionNames': ['Procedure: Post operative enhanced recovery elements']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'who exposed to standard care'}], 'interventions': [{'name': 'Post operative enhanced recovery elements', 'type': 'PROCEDURE', 'description': "According to the study group the researchers collaborated with surgeons, nurses, and anesthesiologists to implement post operative enhanced recovery protocol that defined clearly in the following elements Early nutrition, Early mobilization, Non-opioid analgesia. Early removal of abdominal drains and tubes throughout the patients' hospital stay up to their discharge.", 'armGroupLabels': ['Enhanced recovery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Nursing', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mahmoud Ayoub, Ass. prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University -Assiut city'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor of Medical Surgical Nursing', 'investigatorFullName': 'Amna A. Desouky, MD', 'investigatorAffiliation': 'Assiut University'}}}}