Stopped early
Pediatric Robotic Versus Open Pyeloplasty
NCT04884945 · Indiana University · Updated 6 June 2024
- What is being tested
- Open Pyeloplasty (OP); Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
- For
- Pediatric Urology; Ureteropelvic Junction Obstruction
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 2 years to 8 years. About 11 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 24 Oct 2017, ends 23 June 2021. Registered 13 May 2021.
- Results
- Posted on the registry on 6 June 2024.
In the researchers' words
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.
Sites
- Riley Children's HospitalIndianapolis, Indiana, United States