Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05202158
Status:
UNKNOWN
Last Update Posted:
2022-07-07
First Post:
2022-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Novel Method for Retrograde Intrarenal Surgery (RIRS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of postoperative complications', 'timeFrame': 'One year', 'description': 'Rate of patients who had an complication after the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Stone']}, 'referencesModule': {'references': [{'pmid': '26318710', 'type': 'RESULT', 'citation': 'Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.'}, {'pmid': '27848063', 'type': 'RESULT', 'citation': 'Walton-Diaz A, Vinay JI, Barahona J, Daels P, Gonzalez M, Hidalgo JP, Palma C, Diaz P, Domenech A, Valenzuela R, Marchant F. Concordance of renal stone culture: PMUC, RPUC, RSC and post-PCNL sepsis-a non-randomized prospective observation cohort study. Int Urol Nephrol. 2017 Jan;49(1):31-35. doi: 10.1007/s11255-016-1457-y. Epub 2016 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective randomised controlled study, investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate, intraoperative and postoperative complications during RIRS for kidney stones.', 'detailedDescription': 'Current advances in endoscopic technology for the upper urinary tract have expanded the diagnosis and treatment options for kidney stones. Retrograde intrarenal surgery (RIRS), defined as the use of effective lithotripters such as flexible ureteroscopes (fURSs) and holmium:yttrium aluminum garnet (holmium:YAG) lasers for intrarenal pelvic diseases, is a safe and effective, versatile and minimally invasive procedure for the kidney. . Current guidelines for the treatment of kidney stones recommend RIRS first for stones \\<2 cm. and RIRS as one of the first two options for stones \\>2 cm.. In studies dealing with kidney stones larger than 2 cm, the RIRS showed a cumulative stone-free success of 91%, but a complication rate of 8.6%. Of these, 44% were found to be ≥ Clavien 3 complications. In kidney stone endourological treatments, stone culture was found to be more effective in predicting complications than midstream urine culture. Even if the preoperative midstream urine culture is sterile, complication rates increase if there is bacterial growth in the stone culture in kidney stone surgery. Therefore, although complication rates are generally low, several concerns have arisen. In our study, the investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate and complications during RIRS for kidney stones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<2 cm. kidney stones\n\nExclusion Criteria:\n\n* Ureteral stricture\n* Active urinary tract infection\n* Coagulopathies'}, 'identificationModule': {'nctId': 'NCT05202158', 'briefTitle': 'A Novel Method for Retrograde Intrarenal Surgery (RIRS)', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Training and Research Hospital'}, 'officialTitle': 'A Novel Method for Stone Area Sterilization During Retrograde Intrarenal Surgery (RIRS)', 'orgStudyIdInfo': {'id': 'RIRS2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation + Genta', 'description': 'Patients treated with gentamicin in irrigation fluid during RIRS', 'interventionNames': ['Procedure: Addition of gentamicin to irrigation fluid during RIRS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Irrigation', 'description': 'Patients treated only irrigation fluid during RIRS', 'interventionNames': ['Procedure: Only irrigation fluid during RIRS']}], 'interventions': [{'name': 'Addition of gentamicin to irrigation fluid during RIRS', 'type': 'PROCEDURE', 'description': 'During the RIRS, the access sheath is placed first for security. Then, the stone in the kidney is detected with flexible URS and fragmented with a holmium laser. In this group of patients, 80 mg of gentamicin will be added to 3 liters of irrigation fluid while the stone is being fragmented.', 'armGroupLabels': ['Irrigation + Genta']}, {'name': 'Only irrigation fluid during RIRS', 'type': 'PROCEDURE', 'description': 'During the RIRS, the access sheath is placed first for security. Then, the stone in the kidney is detected with flexible URS and fragmented with a holmium laser. In this group of patients, only irrigation fluid will be used while the stone is fragmented.', 'armGroupLabels': ['Irrigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'Altindag', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Kaan Yildiz', 'role': 'CONTACT', 'email': 'alikaanyildiz@gmail.com', 'phone': '+90 554 773 16 96'}], 'facility': 'Ankara Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ali Kaan Yildiz', 'role': 'CONTACT', 'email': 'alikaanyildiz@gmail.com', 'phone': '+90 554 773 16 96'}, {'name': 'Esra Gulen Yildiz', 'role': 'CONTACT', 'email': 'esragln90@gmail.com', 'phone': '+90 506 877 47 09'}], 'overallOfficials': [{'name': 'Ali Kaan Yildiz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Training and Resarch Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Kaan Yildiz', 'investigatorAffiliation': 'Ankara Training and Research Hospital'}}}}