Pediatric Robotic Versus Open Pyeloplasty

Stopped early · Not applicable

Conditions studied: Pediatric Urology, Ureteropelvic Junction Obstruction

In brief

The objective is conduct a pilot randomized controlled trial comparing robotic and open techniques for surgical correction of congenital UPJ obstruction (pyeloplasty) in pediatric patients. This study will serve as a proof of concept trial to demonstrate feasibility of recruiting pediatric patients to participate in a randomized study for surgical procedures and delineate patient-centered outcomes. Should this study prove randomization is feasible, a randomized comparative effectiveness trial with sufficient power to determine whether open or robotic-assisted pyeloplasty has superior patient-centered outcomes will be pursued.

Key facts

Study ID

NCT04884945

Run by

Indiana University

People needed

11

Starts

2017-10-24

Expected to finish

2021-06-23

Last updated by the study team

2024-06-06

Who can join

Age: 2 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation
• Patient between age 2 - 8 years old

You may not qualify if…

• Serious comorbidities (cardiovascular or respiratory disease, or other congenital anomalies requiring surgical intervention).
• BMI greater than the 95th %tile for age.

Where it is running

• Riley Children's Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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