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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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