Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-07 @ 6:49 PM
Study NCT ID:
NCT04153461
Status:
UNKNOWN
Last Update Posted:
2019-11-13
First Post:
2019-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-10', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of stone free rate (SFR)', 'timeFrame': '2 years', 'description': 'defined as less than 4mm by non contrast computed tomography'}], 'secondaryOutcomes': [{'measure': 'assessment of haemoglobin loss', 'timeFrame': '2 years', 'description': 'measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)'}, {'measure': 'assessment of pain', 'timeFrame': '2 years', 'description': 'measured by visual analogue scale'}, {'measure': 'assessment of renal function', 'timeFrame': '2 years', 'description': 'measured by serum creatinine measured by Milligram/ deciliter'}, {'measure': 'assessment of patient satisfaction', 'timeFrame': '2 years', 'description': 'measured by freiburg index of patient satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urolithiasis', 'stone, renal', 'nephrolithiasis', 'PNL', 'PCNL', 'NEPHROLITHOTOMY', 'MINIPERC', 'MINI-PERC', 'BLOOD LOSS', 'NEPHROSTOMY SIZE'], 'conditions': ['Urolithiasis', 'Stone;Renal', 'Nephrolithiasis', 'PNL', 'PCNL', 'NEPHROLITHOTOMY', 'MINIPERC']}, 'descriptionModule': {'briefSummary': 'The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .\n\nThe aim of this study is to compare between PNL and mPNL through a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient 18 years or older.\n2. ASA I or II\n3. Renal stones ≥ 2 cm\n4. Lower calyceal stone ≥ 1 cm\n5. Failure of other modalities of treatment as ESWL and RIRS.\n\nExclusion Criteria:\n\n1. S.creatinine \\> 2mg/dl.\n2. Patients with active UTI.\n3. Patients on anticoagulant.\n4. Age \\<18 years.\n5. Ureteral obstruction preventing the insertion of a ureteral stent.'}, 'identificationModule': {'nctId': 'NCT04153461', 'briefTitle': 'Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MiniPNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MINI-PERCUTANEOUS NEPHROLITHOTOMY', 'description': 'MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION', 'interventionNames': ['Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'STANDARD PERCUTANEOUS NEPHROLITHOTOMY', 'description': 'PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION', 'interventionNames': ['Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY']}], 'interventions': [{'name': 'MINI-PERCUTANEOUS NEPHROLITHOTOMY', 'type': 'PROCEDURE', 'otherNames': ['MINIPERC', 'MINI-PERC'], 'description': 'MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION', 'armGroupLabels': ['MINI-PERCUTANEOUS NEPHROLITHOTOMY']}, {'name': 'STANDARD PERCUTANEOUS NEPHROLITHOTOMY', 'type': 'PROCEDURE', 'otherNames': ['PNL', 'PCNL', 'STANDARD PNL'], 'description': 'PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION', 'armGroupLabels': ['STANDARD PERCUTANEOUS NEPHROLITHOTOMY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mostafa Elgamal', 'investigatorAffiliation': 'Mansoura University'}}}}