Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05822518
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2023-04-01', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'The number of postoperative complications, either infectious or non-infectious. Postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.'}, {'measure': 'Wound healing', 'timeFrame': '30 days', 'description': 'The number of properly healed wounds. wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.'}, {'measure': 'infectious complications', 'timeFrame': '30 days', 'description': 'infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'will be measured by number of days of hospital stay.'}, {'measure': 'Length of ICU stay', 'timeFrame': '30 days', 'description': 'will be measured by number of days of ICU stay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radical cystectomy', 'complications', 'immune-nutrition', 'immune enhancing nutrition', 'bladder cancer', 'muscle invasive bladder cancer'], 'conditions': ['Cancer, Bladder', 'Cystostomy; Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with CT showing bladder mass with radiological staging of T2 or T3.\n2. Patients pathologically proven to have cancer bladder.\n3. Patients undergoing radical cystectomy with ileal conduit.\n4. The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.\n\nExclusion Criteria:\n\n1. Coagulopathy.\n2. Distant metastasis.\n3. Body mass index less than 18.5.\n4. Relevant food allergies.\n5. Severe renal and hepatic insufficiency.'}, 'identificationModule': {'nctId': 'NCT05822518', 'briefTitle': 'Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy', 'orgStudyIdInfo': {'id': 'Nutrition in R.cystectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'conventional protocol group', 'description': 'patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'immune enhancing nutrition protocol group', 'description': 'patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.', 'interventionNames': ['Dietary Supplement: Neo-mune powder (otsuka pharmaceutical)', 'Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)']}], 'interventions': [{'name': 'Neo-mune powder (otsuka pharmaceutical)', 'type': 'DIETARY_SUPPLEMENT', 'description': '* Preoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 3 days.\n* Postoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 2 weeks starting when the intestinal sounds are audible.', 'armGroupLabels': ['immune enhancing nutrition protocol group']}, {'name': 'Dipeptiven solution (Fresenius Kabi pharmaceutical)', 'type': 'DRUG', 'description': 'Dipeptiven (Fresenius Kabi pharmaceutical) solution 50 mg o.d IV ( contains L-ananyl-L-glutamine dipeptide) post operatively for 5 days starting from the operation day.', 'armGroupLabels': ['immune enhancing nutrition protocol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13829', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'country': 'Egypt', 'facility': 'Menoufia Faculty of Medicine', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ammar Fathi Mohamed AlOrabi', 'investigatorFullName': 'Ammar Fathi Mohamed AlOrabi', 'investigatorAffiliation': 'Menoufia University'}}}}