Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:54 AM
Study NCT ID:
NCT07371494
Status:
COMPLETED
Last Update Posted:
2026-01-28
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones ≤20 mm: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone-free rate (SFR)', 'timeFrame': '1 month after surgery', 'description': 'Stone-free rate was defined as the absence of residual stone fragments \\>4 mm in maximal diameter on postoperative imaging. Stone-free status was assessed using plain abdominal radiography (KUB) on postoperative day 1 and non-contrast computed tomography (CT) at 1 month after surgery. The stone-free rate was determined based on the 1-month CT findings.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Calculi (Kidney Stones) ≤ 20 mm']}, 'descriptionModule': {'briefSummary': 'Kidney stones measuring 20 mm or less are commonly managed using minimally invasive surgical techniques. Two widely used approaches are Super-mini Percutaneous Nephrolithotomy (SMP) and Flexible Ureteroscopy (fURS). Although both techniques are considered effective and safe, they differ in surgical approach, use of disposable equipment, postoperative recovery, and treatment cost. In resource-limited settings, economic considerations may play an important role in treatment selection.\n\nThis single-center randomized controlled trial was conducted at Bach Mai Hospital, Hanoi, Vietnam, to compare clinical outcomes, safety, and direct medical costs of SMP versus fURS in patients with renal stones ≤20 mm. Eligible patients were randomly assigned in a 1:1 ratio to undergo either SMP or fURS.\n\nThe primary outcome was the stone-free rate assessed by postoperative imaging. Secondary outcomes included operative time, postoperative complications, length of hospital stay, hemoglobin drop, and total direct treatment cost per case. The results of this study aim to provide evidence to support clinical decision-making for the management of renal stones, particularly in healthcare settings with limited resources.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years of age).\n* Patients with renal stones measuring ≤20 mm in maximal diameter on preoperative imaging.\n* No prior surgical or interventional procedure during the same hospital admission.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Coagulation disorders or bleeding diathesis contraindicating surgery.\n* Contraindications to either Super-mini Percutaneous Nephrolithotomy (SMP) or Flexible Ureteroscopy (fURS).\n* Patients undergoing SMP or fURS for ureteral stones that migrated back into the kidney.'}, 'identificationModule': {'nctId': 'NCT07371494', 'briefTitle': 'Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones ≤20 mm: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': 'SUPER-MINI PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROSCOPY FOR RENAL STONES 20 MM OR LESS: A SINGLE-CENTER RANDOMIZED CONTROLLED TRIAL ASSESSING COST - ANALYSIS AND SAFETY IN NORTHERN VIETNAM', 'orgStudyIdInfo': {'id': 'No. 876/GCN-HĐĐĐNCYSH-ĐHYHN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMP group', 'interventionNames': ['Procedure: Super-mini Percutaneous Nephrolithotomy']}, {'type': 'EXPERIMENTAL', 'label': 'fURS group', 'interventionNames': ['Procedure: Flexible Ureteroscopy']}], 'interventions': [{'name': 'Super-mini Percutaneous Nephrolithotomy', 'type': 'PROCEDURE', 'description': 'Surgical removal of renal stones using super-mini PCNL technique', 'armGroupLabels': ['SMP group']}, {'name': 'Flexible Ureteroscopy', 'type': 'PROCEDURE', 'description': 'Endoscopic treatment of renal stones using flexible ureteroscope', 'armGroupLabels': ['fURS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Bach Mai Hospital, Department of Urology', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}