Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 6:17 AM
Study NCT ID:
NCT06960135
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors', 'timeFrame': '2 years', 'description': 'Trifecta achievement is defined as the combination of (1) negative surgical margins, (2) absence of perioperative complications classified as Clavien-Dindo grade III or higher, and (3) warm ischemia time ≤25 minutes.\n\nfactors affecting trifecta achievement among variables including tumor complexity score, patient comorbidities, BMI, surgical approches, special habbites, age or gender.'}], 'secondaryOutcomes': [{'measure': 'Pentafecta Achivement', 'timeFrame': '2 yrs', 'description': 'Pentafecta achievement is defined as the combination of:\n\n1. negative surgical margins,\n2. absence of major perioperative complications (Clavien-Dindo grade ≥III),\n3. warm ischemia time ≤25 minutes,\n4. ≥90% preservation of preoperative estimated glomerular filtration rate (eGFR), and\n5. no progression to a higher CKD stage at 12 months postoperative follow-up. Data will be collected from surgical, pathological, and clinical records. Predictors of Pentafecta achievement will be analyzed using multivariable logistic regression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic, Partial Nephrectomy', 'Trifecta, Pentafecta Achievement', 'Renal Tumors'], 'conditions': ['Trifecta Achievement', 'Pentafecta Achievement']}, 'descriptionModule': {'briefSummary': 'Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.\n\nObjectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.', 'detailedDescription': 'Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patients who are fit for surgery.\n\n * Patients with renal tumor who are indicated for partial nephrectomy\n\nAbsolute:\n\n1. Solitary kidney.\n2. Bilateral renal tumor.\n3. CDK.\n\nRelative:\n\n1. Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).\n2. Metabolic disease associated with renal failure (DM, hypertension).\n3. Genetic syndrome with tumor multifocality (VHL syndrome). Elective\n\n1\\. Clinical T1N0M0 Tumor. 2. Peripheral tumor.\n\nExclusion Criteria:\n\n* • Patients who are unfit for surgery and who's unfit for laparoscopy.\n\n * Patients who are contraindicated for partial nephrectomy. As severe and irreversible coagulopathy. Patients who are indicated for radical nephrectomy (extensive tumor, metastatic tumor)."}, 'identificationModule': {'nctId': 'NCT06960135', 'acronym': 'Trifecta', 'briefTitle': 'Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors', 'orgStudyIdInfo': {'id': 'SVU-MED-URO016-2-22-5-400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open partial nephrectomy', 'description': 'open partial nephrectomy', 'interventionNames': ['Procedure: open partial nephrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic partial nephrectomy', 'description': 'laparoscopic partial nephrectomy', 'interventionNames': ['Procedure: laparoscopic partial nephrectomy']}], 'interventions': [{'name': 'open partial nephrectomy', 'type': 'PROCEDURE', 'description': 'open partial nephrectomy', 'armGroupLabels': ['open partial nephrectomy']}, {'name': 'laparoscopic partial nephrectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic partial nephrectomy', 'armGroupLabels': ['laparoscopic partial nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83511', 'city': 'Qena, Egypt', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'SVU hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Omar Ahmad Bakheet', 'investigatorAffiliation': 'South Valley University'}}}}