Stopped: Unable to resume recruitment post COVID.
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.
Age range
2 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Length of Post Op Inpatient Hospital Stay Measured in Days
Timeframe: surgery to discharge
Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op
Timeframe: Surgery to the first 24 hours post op
Total Dose of Narcotic Pain Medication In the First 24 Hours Post Op in Morphine Milligram Equivalents (MME)
Timeframe: Surgery to the first 24 hours post op
Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification
Timeframe: up to 1 year post up
Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up
Timeframe: 1 week post op follow up
Length Of Time For Patient To Return To Normal Routine After Surgery Measured in Days at 2 Week Post Follow Up
Timeframe: 2 week post op follow up
Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up
Timeframe: 2 week post op follow up
Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit
Timeframe: up to 3 month follow up visit (18 weeks post op)
Satisfaction With Symptoms Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit
Timeframe: up to 3 month follow up visit (18 weeks post op)
Quality of Life Measured Using The Glasgow Children's Benefit Inventory at 3 Month Follow Up Visit
Timeframe: 3 month follow up visit