Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-13 @ 7:51 AM
Study NCT ID:
NCT06592469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018666', 'term': 'Ureteroscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter', 'timeFrame': '1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative', 'description': '• Stone free rate with a mean operative time of 1 hr by MSCTKUB or Plain KUB to determine residual stones post operative'}], 'secondaryOutcomes': [{'measure': '• Rate of intraoperative findings in each group.', 'timeFrame': 'Intraoperative', 'description': '• Rate intraoperative findings in each group by ureteroscope'}, {'measure': '• The rate of complication in each group', 'timeFrame': 'Intraoperative by ureteroscope and one day post operative by MSCT', 'description': 'To determine rate of intraoperative complications as bleeding , ureteric perforation , residual stones'}, {'measure': '• The rate of stone impaction in each group', 'timeFrame': 'Intraoperative by ureteroscope', 'description': 'Rate of stone impaction in each group fresh and recurrent cases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['URS'], 'conditions': ['Stone Ureter']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33818430/', 'label': 'Factors predicting duration and success of semirigid ureteroscopy for ureteral stones in different localizations'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6060607/', 'label': 'Assessment of factors affecting the spontaneous passage of lower ureteric calculus on the basis of lower ureteric calculus diameter, density, and plasma C-reactive protein level. Urology Annal'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30719571/', 'label': 'Stone composition independently predicts stone size in 18,029 spontaneously passed stones'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103480/', 'label': 'Outcomes of Shock Wave Lithotripsy and Ureteroscopy for Treatment of Pediatric Urolithiasis'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/24890883/', 'label': 'Pushing the boundaries of ureteroscopy: current status and future perspectives'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32459149/', 'label': 'Semirigid Ureteroscopy: Step by Step'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/15735383/', 'label': 'Complications of pneumatic ureterolithotripsy in the early postoperative period'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/16548724/', 'label': 'Complications of 2735 retrograde semirigid ureteroscopy procedures: a single-center experience'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/14665851/', 'label': 'Endoscopic features of impacted ureteral stones'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/18632141/', 'label': 'Predictive factors for intraoperative complications in semirigid ureteroscopy: analysis of 1235 ballistic ureterolithotripsies'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/22641488/', 'label': 'Revisiting the predictive factors for intra-operative complications of rigid ureteroscopy: a 15-year experience'}]}, 'descriptionModule': {'briefSummary': 'Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter', 'detailedDescription': 'Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '.4. 2- Study subjects:\n\n1. Inclusion criteria:\n\n * all cases with middle and lower ureteric stone candidate for endoscopy.\n * Stone 15mm or less.\n2. Exclusion criteria:\n\n * Patients with a ureteral stent.\n * Patient refusing participation.\n * Pregnant woman.\n * Active urinary tract infection.\n * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.\n3. Sample Size Calculation:\n\nBased on previously reported frequency of primary failure of ureteocopy in case of recurrent stone that ranged between 1-37% (\\*reference)\\* a total sample size of 62 patients will be required ( 31 patients in each arm) with the following assumption; alpha error 5%, 80% power with 95% confidence interval', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • all cases with middle and lower ureteric stone candidate for endoscopy.\n\n * Stone 15mm or less.\n\nExclusion Criteria:\n\n* • Patients with a ureteral stent.\n\n * Patient refusing participation.\n * Pregnant woman.\n * Active urinary tract infection.\n * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.'}, 'identificationModule': {'nctId': 'NCT06592469', 'briefTitle': 'Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Outcome of Ureteroscopy in Fresh Versus Recurrent Cases of Stone Ureter (Post-ESWL, Endoscopy, or Open Surgery)', 'orgStudyIdInfo': {'id': 'Outcome of Ureteroscopy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fresh cases', 'description': 'Outcome of URS in fresh stone ureter', 'interventionNames': ['Procedure: Ureteroscopy']}, {'label': 'Recurrent cases', 'description': 'Outcome of URS in recurrent cases of stone ureter post ESWL ,URS , open surgery', 'interventionNames': ['Procedure: Ureteroscopy']}], 'interventions': [{'name': 'Ureteroscopy', 'type': 'PROCEDURE', 'otherNames': ['URS'], 'description': 'URS is done to each group to reveal outcome of stone free rate in fresh versus recurrent cases of stone ureter', 'armGroupLabels': ['Fresh cases', 'Recurrent cases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Medicine Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Amr Moustafa Hussein Soliman, Resident dr', 'role': 'CONTACT', 'email': 'amr.mustafa303@gmail.com', 'phone': '+201140340697'}], 'overallOfficials': [{'name': 'Fathy Gaber Mahmoud Alanany, Prof of URO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Mahmoud M. Shalaby, Prof of URO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Nasreldin Abdeal Mohammed, Ass Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Amr Moustafa Hussein Soliman', 'investigatorAffiliation': 'Assiut University'}}}}