Pediatric Robotic Versus Open Pyeloplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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Technological innovations are an ongoing reality in clinical medicine, most dramatically in the operating room. Each advance is often heralded as an improvement in patient care, promising to correct deficiencies and advance standard operative procedures. Unfortunately, these new technologies often lack sufficient evidence to support such claims. Robotic assisted laparoscopic (RAL) surgery continues to gain popularity among pediatric surgical specialists, particularly for reconstructive procedures such as correction of ureteropelvic junction (UPJ) obstruction or vesicoureteral reflux (VUR).In these operations, where traditional open surgery yields a nearly 95% clinical success rate it is difficult to demonstrate improvement with a new surgical technique. Despite these impressive outcomes with the open approach many pediatric urologists are shifting towards newer RAL approaches, claiming faster recovery and improved cosmesis with a nominal increase in surgical cost. There is a striking dearth of comparative effectiveness research in pediatric surgical specialties, especially given the wide range of available therapies for a variety of surgical problems. Conducting randomized controlled trials of surgical interventions can be very difficult, especially in the pediatric population. Currently, all studies of pediatric robotic surgery have focused on traditional outcomes, e.g., length of stay, pain scores, pain medication usage, scar perception, cost analysis, and capital gains benefits. While these measures are important to study, the investigators believe that researchers must also focus on patients' treatment experiences or patients' evaluations of their own outcomes. By focusing on these 'patient-centered outcomes' the investigators will be able to improve outcomes from surgical procedures in ways that are most important to patients and their families. We propose 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, the investigators will seek funding to conduct a large, randomized comparative effectiveness trial with sufficient power to determine whether open or robotic-assisted pyeloplasty has superior patient-centered outcomes. The investigators propose to accomplish these goals with the following Specific Aims: Aim 1: Utilize novel patient-centered research methods to: Identify outcomes of importance to patients and families related to pediatric pyeloplasty. Determine patient and family preferences regarding acceptability of randomization and blinding of pediatric surgical patients and construct a recruitment approach to achieve enrollment. Aim 2: Conduct a randomized pilot study with goal of enrolling ten to twenty pediatric patients (age 2 - 8 years) to either open or robotic pyeloplasty for treatment of primary UPJ obstruction. Sub Aim 2a: Collect preliminary data regarding the patient-centered outcomes identified in Aim 1. Sub Aim 2b: Evaluate the effectiveness of the recruitment approach for randomized surgical studies developed in Aim 1. The investigators believe that the use of innovative and novel patient-centered research methods will lead to a significant breakthrough in developing a recruitment approach that is both acceptable to pediatric patients/families and optimizes participant willingness to participate in RCTs of surgical interventions. Additionally these same innovative research methods will allows the investigators to explore what outcomes are meaningful to patients and families, which will hopefully allow the care team to counsel patients and families in a way that maximizes their chances of achieving patient- and family-centered goals.

Official Title
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Pediatric Robotic Versus Open Pyeloplasty: A Pilot Randomized Control Study

Conditions
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Pediatric Urology, Ureteropelvic Junction Obstruction

Intervention / Treatment
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* Procedure: Open Pyeloplasty (OP)
* Procedure: Robotic-Assisted Laparoscopic Pyeloplasty (RALP


Participation Criteria
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Eligibility Criteria
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For Aim 2: Inclusion Criteria: Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation Patient between age 2 - 8 years old Exclusion Criteria: Serious comorbidities (cardiovascular or respiratory disease, or other congenital anomalies requiring surgical intervention). BMI greater than the 95th %tile for age.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For Aim 2: For the RCT, patients are randomized to either RALP or OP by using a pool of 20 cards of which 10 say robotic surgery and 10 say open surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic Surgery<br>Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction | Procedure: Robotic-Assisted Laparoscopic Pyeloplasty (RALP<br>* Robotic approach for the surgical correction of UPJ obstruction<br>|
| Active Comparator: Open Surgery<br>Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction | Procedure: Open Pyeloplasty (OP)<br>* Open approach for the surgical correction of UPJ obstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay (days) | Number of inpatient hospital days post surgery obtained via retrospective chart review by RA | up to 1 week post op | 
| Pain Medication Use (dose/frequency) | Pain medication use during hospitalization obtained via retrospective chart review by RA. Dose recorded in mg and frequency recorded as number of doses administered in 24 hour period | up to 1 week post op | 
| Surgical complications | Complications during hospitalization obtained via retrospective chart review by RA, using Clavian-Dindo classification | up to 1 year post op | 
| Total Hospital Charges and Estimated Costs | PHIS (Pediatric Health information System) database query for charge and cost data submitted by the hospital for surgery and subsequent hospitalization | up to 1 week post op | 
| Pain Scores | Obtained from hospital record and participant report post discharge via the FLACC (behavioral scale for scoring postoperative pain in young children). FLACC score range: minimum 0 ( comfortable) and 10 (severe discomfort) | up to 2 week post op | 
| Patient Experience | Participant to complete questionnaire with targeted questions on: Side effects of medication and impact; Experience of having a temporary ureteral stent; Ease of removing stent; Return to activity; Financial burden reported by family. No scale or scoring utilized to assess outcome. | 2 week post op follow up | 
| Time until parental return to work | Number of days parent out of work after operation obtained by parent report. No scale or scoring utilized to assess outcome. | 2 week post op follow up | 
| Scar perception | Participant to complete the Patient Scar Assessment Questionnaire (PSAQ). PSAQ with sub scales with scoring 1 (most favorable) to 4 (least favorable). Subscales: Appearance minimum  9 and maximum 36;Consciousness minimum  6 and maximum 24; Satisfaction with Appearance minimum 8 and maximum 32; Satisfaction with Symptoms minimum 5 and maximum 20 | up to 12 weeks post op | 
| Quality of Life (post intervention) | Participant to complete Glasgow Children's Benefit Inventory (GCBI). 24 question 5 point Likert scale 1 (much better) to 5 (much worse) with scoring range 24 to 120 | up to 12 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient centered outcomes