Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:54 AM
Study NCT ID:
NCT07310966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone Free Rate', 'timeFrame': '1 month', 'description': 'Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'The operative time', 'description': 'operative time is defined as time between starting the procedure and termination of it measured in minutes'}, {'measure': 'Complications', 'timeFrame': '1 month', 'description': 'Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lithotomy position', 'lateral position', 'lower calyx', 'FURS', 'RIRS'], 'conditions': ['Renal Calculi']}, 'descriptionModule': {'briefSummary': 'Retrograde intrarenal surgery (RIRS) is an established minimally invasive treatment for renal stones, particularly for lower calyceal stones less than 2 cm, offering acceptable stone-free rates with low morbidity.\n\nHowever, stone clearance in the lower calyx remains technically challenging due to unfavorable anatomy, limited scope deflection, and gravity-dependent fragment retention. Patient positioning during RIRS has been suggested as a modifiable factor that may influence endoscopic access, stone relocation, and surgical ergonomics.\n\nThe lithotomy position is conventionally used during RIRS, while the lateral position has been proposed to facilitate stone migration and improve lower calyceal access through gravitational assistance. Existing studies comparing patient positioning during RIRS are limited, with most evidence derived from retrospective analyses or non-randomized designs.\n\nTherefore, this randomized controlled trial aims to compare lithotomy versus lateral positioning during RIRS for lower calyceal stones less than 2 cm in terms of operative and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Single or multiple lower calyceal renal stones with stone size \\<2 cm confirmed by NCCT.\n* Negative urine culture.\n* Presented cases.\n\nExclusion Criteria:\n\n* Multiple stones involving renal pelvis or other calyces.\n* Anatomical anomalies affecting ureteroscope access (horseshoe kidney, malrotation, ureteral strictures).\n* Pregnancy.\n* Prior ipsilateral renal surgery.'}, 'identificationModule': {'nctId': 'NCT07310966', 'briefTitle': 'Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Patient position in RIRS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lithotomy position group', 'description': 'patients of this group undergo RIRS in Lithotomy position', 'interventionNames': ['Procedure: Lithotomy Position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lateral position group', 'description': 'patients of this group undergo RIRS in lateral position', 'interventionNames': ['Procedure: Lateral position']}], 'interventions': [{'name': 'Lithotomy Position', 'type': 'PROCEDURE', 'description': 'Patients undergo RIRS in lithotomy position', 'armGroupLabels': ['Lithotomy position group']}, {'name': 'Lateral position', 'type': 'PROCEDURE', 'description': 'Patients undergo RIRS in lateral position', 'armGroupLabels': ['Lateral position group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shebin El-Kom', 'state': 'Menoufia', 'country': 'Egypt', 'contacts': [{'name': 'Ammar Aziz', 'role': 'CONTACT', 'email': 'ammar.alorabi95@gmail.com', 'phone': '+201097991198'}], 'facility': 'Menoufia Faculty of Medicine'}], 'centralContacts': [{'name': 'Ammar Alorabi', 'role': 'CONTACT', 'email': 'ammar.alorabi95@gmail.com', 'phone': '+201067608011'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ammar Fathi Mohamed AlOrabi', 'investigatorAffiliation': 'Menoufia University'}}}}