Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 3:58 AM
Study NCT ID:
NCT04732403
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ureteral Jets and Patient Positioning Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to confirmation of bilateral ureteral patency', 'timeFrame': '1 day', 'description': 'time between initiation of cystoscopy and visualization of second ureteral jet in minutes'}], 'secondaryOutcomes': [{'measure': 'total cystoscopy time', 'timeFrame': '1 day', 'description': 'Total time of cystoscopy'}, {'measure': 'need for alternative modalities to aid in ureteral efflux visualization', 'timeFrame': '1 day', 'description': 'After 10 minutes of no jet, it is okay for the surgeon to use alternative methods, including dextrose, sodium fluorescein, indigo carmine, IV diuretics, etc.'}, {'measure': 'delayed diagnosis of ureteric injury', 'timeFrame': '6 weeks after surgery', 'description': 'evaluated 6 weeks postoperatively via chart review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ureteral injury', 'cystoscopy', 'hysterectomy', 'gynecologic surgery'], 'conditions': ['Ureteral Injury', 'Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '26551173', 'type': 'BACKGROUND', 'citation': 'Teeluckdharry B, Gilmour D, Flowerdew G. Urinary Tract Injury at Benign Gynecologic Surgery and the Role of Cystoscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Dec;126(6):1161-1169. doi: 10.1097/AOG.0000000000001096.'}, {'pmid': '15902164', 'type': 'BACKGROUND', 'citation': 'Vakili B, Chesson RR, Kyle BL, Shobeiri SA, Echols KT, Gist R, Zheng YT, Nolan TE. The incidence of urinary tract injury during hysterectomy: a prospective analysis based on universal cystoscopy. Am J Obstet Gynecol. 2005 May;192(5):1599-604. doi: 10.1016/j.ajog.2004.11.016.'}, {'pmid': '15625150', 'type': 'BACKGROUND', 'citation': 'Gilmour DT, Baskett TF. Disability and litigation from urinary tract injuries at benign gynecologic surgery in Canada. Obstet Gynecol. 2005 Jan;105(1):109-14. doi: 10.1097/01.AOG.0000144127.78481.8c.'}, {'pmid': '21886472', 'type': 'BACKGROUND', 'citation': 'Delacroix SE Jr, Winters JC. Urinary tract injuries: recognition and management. Clin Colon Rectal Surg. 2010 Sep;23(3):221. doi: 10.1055/s-0030-1263063. No abstract available.'}, {'pmid': '15291852', 'type': 'BACKGROUND', 'citation': 'Brandes S, Coburn M, Armenakas N, McAninch J. Diagnosis and management of ureteric injury: an evidence-based analysis. BJU Int. 2004 Aug;94(3):277-89. doi: 10.1111/j.1464-410X.2004.04978.x. No abstract available.'}, {'pmid': '29369837', 'type': 'BACKGROUND', 'citation': 'Cohen SA, Carberry CL, Smilen SW. American Urogynecologic Society Consensus Statement: Cystoscopy at the Time of Prolapse Repair. Female Pelvic Med Reconstr Surg. 2018 Jul/Aug;24(4):258-259. doi: 10.1097/SPV.0000000000000529.'}, {'pmid': '25833482', 'type': 'BACKGROUND', 'citation': 'Kim JH. Urogynecology and Reconstructive Pelvic Surgery. 4th ed. Int Neurourol J. 2015 Mar;19(1):51. doi: 10.5213/inj.2015.19.1.51. No abstract available.'}, {'pmid': '22748947', 'type': 'BACKGROUND', 'citation': 'AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL Practice Report: Practice guidelines for intraoperative cystoscopy in laparoscopic hysterectomy. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):407-11. doi: 10.1016/j.jmig.2012.05.001.'}, {'pmid': '36103970', 'type': 'DERIVED', 'citation': 'Galhotra S, Zeng K, Hu C, Norton T, Mahnert N, Smith R, Mourad J. The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2023 Jan;30(1):13-18. doi: 10.1016/j.jmig.2022.09.003. Epub 2022 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.', 'detailedDescription': 'Patients will be randomized to one of two arms: 0 degree supine position and 10-20 degree angle in reverse Trendelenburg. Our working hypothesis is that positioning a patient in 10-20 degree angle reverse Trendelenburg will result in shorter time to confirmation of bilateral ureteral patency and shorter total cystoscopy time, without a change in delayed diagnosis of ureteric injury.\n\nPrimary outcome: time to confirmation of bilateral ureteral patency Secondary outcome: total cystoscopy time, need for alternative modalities to aid in ureteral efflux visualization, delayed diagnosis of ureteric injury (evaluated 6 weeks postoperatively via chart review)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients\n2. Greater than or equal to 18 years old\n3. English-speaking\n4. Scheduled benign gynecologic or urogynecologic surgery in which routine cystoscopy at Banner University Medical Center - Phoenix; Dr. Mourad, Dr. Mahnert or Dr. Rachael Smith.\n\nExclusion Criteria:\n\n1. Patients with underlying chronic kidney disease (creatinine \\<1)\n2. Known renal anomaly such as prior surgical removal of a kidney or underlying ureteral obstruction\n3. Current ureteral stent in place,\n4. Pregnancy,\n5. Contraindication to any of the interventions (i.e., documented allergies)'}, 'identificationModule': {'nctId': 'NCT04732403', 'briefTitle': 'Ureteral Jets and Patient Positioning Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2011188102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '0 degree supine position', 'description': 'Surgical bed will be set to a 0 degree supine position'}, {'type': 'EXPERIMENTAL', 'label': '10-20 degree angle in reverse Trendelenburg', 'description': 'Surgical bed will be set to a 10-20 degree angle in reverse Trendelenburg', 'interventionNames': ['Other: Patient Position']}], 'interventions': [{'name': 'Patient Position', 'type': 'OTHER', 'description': 'The patient will be placed in an angle on the surgical table during cystoscopy.', 'armGroupLabels': ['10-20 degree angle in reverse Trendelenburg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Jamal Mourad, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}