Pediatric Robotic Versus Open Pyeloplasty

May 8, 2024 updated by: Benjamin Whittam, Indiana University

Pediatric Robotic Versus Open Pyeloplasty: A Pilot Randomized Control Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46201
        • Riley Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robotic Surgery
Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction
Device: Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction
Active Comparator: Open Surgery
Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction
Procedure: Open Pyeloplasty (OP)
Open approach for the surgical correction of UPJ obstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Post Op Inpatient Hospital Stay Measured in Days
Time Frame: surgery to discharge
Number of inpatient hospital days post surgery obtained via retrospective chart.
surgery to discharge
Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op
Time Frame: Surgery to the first 24 hours post op
Pain medication use during hospitalization obtained via retrospective chart review. Dose recorded in mg and frequency recorded as number of doses administered in 24 hour period
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)
Time Frame: Surgery to the first 24 hours post op
Pain medication use during hospitalization obtained via retrospective chart review. Morphine milligram equivalents (MME) are values that represent the potency of an opioid dose relative to morphine
Surgery to the first 24 hours post op
Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification
Time Frame: up to 1 year post up

This s a standardized scale to rank the severity of a surgical complication. The higher the grade the more severe the surgical complication. Minimum value is Grade "0" no complication to maximum Grade IV life threatening complication. Grades I thru IV defined as:

Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

This grade also includes wound infections opened at the bedside ; Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Blood transfusionsand total parenteral nutritionare also included; Grade III Requiring surgical, endoscopic or radiological intervention; Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management
up to 1 year post up
Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up
Time Frame: 1 week post op follow up
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)
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
Time Frame: 2 week post op follow up
Study team created a questionnaire to better understand patient's post op 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
Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up
Time Frame: 2 week post op follow up

Number of days parent out of work after operation obtained by parent report. No scale or scoring utilized to assess outcome.

Participant asked "Have you returned to work since your child's surgery?". If "Yes", asked to estimate the length of time you were out of work after your child's operation.
2 week post op follow up
Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit
Time Frame: up to 3 month follow up visit (18 weeks post op)
Participant completed the Patient Scar Assessment Questionnaire (PSAQ) at 3 month follow up visit. The 3 month follow up was scheduled at the 6 week post op visit. The "Satisfaction with Appearance" subscale consists of a 8 items with 4-point categorical responses, scoring 1 to 4 points (with 1 point assigned to the most favourable category and 4 assigned to the least favourable). The minimum score of this scale is an "8" and maximum "32."
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
Time Frame: up to 3 month follow up visit (18 weeks post op)

The Patient Scar Assessment Questionnaire (PSAQ) was completed at the 3 month follow up (scheduled at the 6 week post op visit).

Higher scores reflect a poorer perception of the scar related to the domain being evaluated. The "Satisfaction with Symptoms" subscale consists of a 5 items with 4-point categorical responses, scoring 1 to 4 points (with 1 point assigned to the most favourable category and 4 assigned to the least favourable). The minimum score of this scale is an "5" and maximum "20.
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
Time Frame: 3 month follow up visit

Participant completed the GCBI at 3 month follow up visit. The 3 month follow up was scheduled at the 6 week post op visit.

The Glasgow Children's Benefit Inventory (GCBI). is a 24 question 5 point Likert scale 2 (much better) to -2 (much worse) with scoring range from -100 (maximum harm) to +100 (maximum benefit).
3 month follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Benjamin Whittam, MD, Riley Children's Health, Indiana University Health, Pediatric Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1403886306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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