Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 11:12 PM
Study NCT ID:
NCT03719456
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-20', 'studyFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate (SFR)', 'timeFrame': 'It will be assessed by non contrast computed tomography for the participants one month after the procedure', 'description': 'stone free rate after the procedure'}], 'secondaryOutcomes': [{'measure': 'Predictors of operative time of the procedure', 'timeFrame': 'Immediately after the procedure', 'description': 'Predictors of operative time of the procedure'}, {'measure': '- Post-operative complications using modified Dindo-Clavian grading system', 'timeFrame': 'within 30 days after the procedure', 'description': '\\- Post-operative complications (Type/rate/predictors) using modified Dindo-Clavian grading system'}, {'measure': 'Intra-operative clinical judgment of the surgeon on stone free status using flouroscopy and visual scanning of pelvicalyceal system and its relation to post-operative NCCT.', 'timeFrame': 'Post operative day 1 after the procedure', 'description': '\\- Intra-operative surgeon perspective about procedure outcome and its relation to post-operative NCCT.'}, {'measure': '- Patient -reported outcomes about post operative pain using visual analogue scale', 'timeFrame': 'within 3 months after the procedure', 'description': '• Post-operative pain: Postoperative pain will be evaluated in all patients by using visual analogue scale (VAS). The impact of patient-related, stone-related and procedure-related factors.'}, {'measure': 'Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).', 'timeFrame': 'within 3 months after the procedure', 'description': 'Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).'}, {'measure': 'Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)', 'timeFrame': 'within 3 months after the procedure', 'description': 'Procedure impact on improvement in patient-reported outcomes measurements information system (PROMIS): PROMIS is a National Institute of Health (NIH) validated system to assess patient quality of life. The PROMIS survey consists of 43 questions assessing the following categories: anxiety/fear, depression/ sadness, fatigue, pain interference, physical function, and sleep disturbance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal stone', 'Calculi', 'Retrograde Intrarenal Surgery', 'Flexible ureteroscope'], 'conditions': ['Renal Stone']}, 'descriptionModule': {'briefSummary': 'The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. In addition, patient-reported outcomes after this modality of intervention are going to be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to give informed consent.\n2. Stone criteria:\n\n * Less than 20 mm.\n * Infectious stone.\n * Growing stone on follow-up.\n3. Kidney criteria:\n\n * Obstructing stone causing hydronephrosis.\n * Solitary kidney or bilateral renal stones.\n4. Patients criteria:\n\n * Age ≥18 years.\n * Symptomatic stone causing pain or hematuria.\n * Patient comorbidity omitting other modalities as bleeding diathesis or skeletal deformities.\n * Patient preference or patients' social situation concerning profession or amount of travel\n\nExclusion Criteria:\n\n1. Inability to give informed consent.\n2. Stone criteria:\n\n * More than 20 mm.\n * Peripheral calyceal asymptomatic stone static in size on follow-up.\n * Unsuitable/failure of initial treatment modalities (oral dissolution therapy-SWL) for stones less than 20 mm."}, 'identificationModule': {'nctId': 'NCT03719456', 'briefTitle': 'Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm', 'orgStudyIdInfo': {'id': 'AE 2394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible ureteroscope', 'interventionNames': ['Procedure: Retrograde Intrarenal Surgery']}], 'interventions': [{'name': 'Retrograde Intrarenal Surgery', 'type': 'PROCEDURE', 'otherNames': ['Flexible ureteroscope'], 'armGroupLabels': ['Flexible ureteroscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '35516', 'city': 'Al Manşūrah', 'country': 'Egypt', 'facility': 'Amr A Elsawy', 'geoPoint': {'lat': 29.22724, 'lon': 31.01611}}], 'overallOfficials': [{'name': 'Amr A Elsawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amr Abdel-Lateif El-Sawy', 'investigatorAffiliation': 'Mansoura University'}}}}