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Clinical Trial Summary

Ureteropelvic junction obstruction (UPJO) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the U.S. The goal of surgical treatment of UPJO is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60% of infants with high-grade hydronephrosis.1-However, the benefit of early surgery compared to observation and potential later surgery to preserve kidney function has not been well-defined. Consequently, surgeons differ on whether to initially treat with surgery or observation, with surgical rates in the first year of life varying from 15-50% across surgical practices. These variations are important to understand, as the decision for early surgery is not without risk. Prior studies suggest that infants treated surgically are at higher risk for readmission and reoperation. Early surgery also raises concerns about neurodevelopmental effects of anesthetic exposure. To address this gap, the purpose of this pilot test is to develop a patient decision aid (PtDA) tool and pilot test its effect on parental understanding and engagement in the decision-making process at Children's Hospital Colorado. The proposed pilot is a necessary first step in preparation for a future multicenter hybrid effectiveness-implementation trial. This work will also be used to support future studies evaluating the impact of a PtDA on surgical variations and treatment outcomes in patients with UPJO and other complex congenital urologic anomalies.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05900375
Study type Interventional
Source University of Colorado, Denver
Contact Alison Saville, MSPH, MSW
Phone 7202574406
Email alison.saville@cuanschutz.edu
Status Not yet recruiting
Phase N/A
Start date June 15, 2023
Completion date December 31, 2024

See also
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Completed NCT02140970 - Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal N/A
Completed NCT06349161 - Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience
Recruiting NCT05895422 - Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO Phase 3
Recruiting NCT06382233 - The PRO-FUTURE Project
Terminated NCT02713633 - Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty N/A
Recruiting NCT05739812 - The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery N/A
Withdrawn NCT01711996 - The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients