Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-06-14 @ 6:42 AM
Study NCT ID:
NCT05291702
Status:
UNKNOWN
Last Update Posted:
2022-03-23
First Post:
2022-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069856', 'term': 'Staghorn Calculi'}], 'ancestors': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2022-01-30', 'studyFirstSubmitQcDate': '2022-03-13', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate', 'timeFrame': 'The participants will be followed for one month after the procedure', 'description': 'Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB )'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'From the start of the operation and till one month after the patient discharge.', 'description': 'Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure.'}, {'measure': 'Operative time', 'timeFrame': 'Average of three hours', 'description': 'Measurment of the time from start of the operation till fixation of nephrostomy tube'}, {'measure': 'Postoperative pain', 'timeFrame': 'Within 24 hours postoperative and till the patient discharge', 'description': 'Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain.'}, {'measure': 'Hospital stay', 'timeFrame': 'Average of six days', 'description': 'Postoperative hospital stay of the participants till thier discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCNL'], 'conditions': ['Staghorn Calculi']}, 'referencesModule': {'references': [{'pmid': '20811557', 'type': 'BACKGROUND', 'citation': 'Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.'}, {'type': 'BACKGROUND', 'citation': 'Turk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.'}, {'pmid': '27238616', 'type': 'BACKGROUND', 'citation': 'Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.'}, {'pmid': '26242465', 'type': 'BACKGROUND', 'citation': 'Zhu W, Liu Y, Liu L, Lei M, Yuan J, Wan SP, Zeng G. Minimally invasive versus standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. 2015 Nov;43(6):563-70. doi: 10.1007/s00240-015-0808-y. Epub 2015 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract', 'detailedDescription': 'Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.\n\nTotal stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.\n\nBased on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients more than 18 years old.\n2. Patients with staghorn stone (partial, complete).\n3. Patients with multiple calyceal calculi which are inaccessible by single tract.\n\nExclusion Criteria:\n\n1. Patients under 18 years old.\n2. Patients with renal anomalies.\n3. Patients with only function kidney.\n4. Patients with distal ureteric obstruction.\n5. Patients with radiolucent stone.\n6. Patients with febrile urinary tract infection.\n7. Patients with abnormal coagulopathy state.\n8. Patients refused to participate in this study.\n9. pregnancy.\n10. Musculoskeletal deformity.'}, 'identificationModule': {'nctId': 'NCT05291702', 'acronym': 'PCNL', 'briefTitle': 'Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Multitract PCNL as One Step for Management of Large Renal Stones', 'orgStudyIdInfo': {'id': 'Multitract PCNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Multitract PCNL patients', 'description': 'Assessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy.', 'interventionNames': ['Procedure: PCNL']}], 'interventions': [{'name': 'PCNL', 'type': 'PROCEDURE', 'description': 'Percutaneous nephrolithotomy ( Extraction of the renal stones using the nephroscope/ Ureteroscope )', 'armGroupLabels': ['Multitract PCNL patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Waleed Mahmoud Abbas, M.Sc', 'role': 'CONTACT', 'email': 'Dr_walidws@yahoo.com', 'phone': '+2001009377858'}, {'name': 'Mohamed Ali Zarzour, MD', 'role': 'CONTACT', 'email': 'Dr-mohamedali81@yahoo.com', 'phone': '+2001014714142'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Waleed Mahmoud Ali Abbas', 'investigatorAffiliation': 'Assiut University'}}}}