Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
11 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-24
Study Completion Date
2021-06-23
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.
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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.
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.
Conditions
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Pediatric Urology
Ureteropelvic Junction Obstruction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Participants
Caregivers
Patient, Family, and Nursing Staff on Surgical Floor
Study Groups
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Robotic Surgery
Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction
Group Type
ACTIVE_COMPARATOR
Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
Intervention Type
DEVICE
Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction
Open Surgery
Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction
Group Type
ACTIVE_COMPARATOR
Open Pyeloplasty (OP)
Intervention Type
PROCEDURE
Open approach for the surgical correction of UPJ obstruction
Interventions
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Open Pyeloplasty (OP)
Open approach for the surgical correction of UPJ obstruction
Intervention Type
PROCEDURE
Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation
* Patient between age 2 - 8 years old
* 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.
* BMI greater than the 95th %tile for age.
Minimum Eligible Age
2 Years
Maximum Eligible Age
8 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Benjamin Whittam
Associate Professor Urology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Benjamin Whittam, MD
Role: PRINCIPAL_INVESTIGATOR
Riley Children's Health, Indiana University Health, Pediatric Urology
Locations
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Riley Children's Hospital
Indianapolis, Indiana, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1403886306
Identifier Type: -
Identifier Source: org_study_id
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