Randomized Robotic-Assisted versus Open surgery: Benefits and Patient Centered Outcomes Trial(Randomized ROBOT)

Project: Research project

Project Details

Description

? DESCRIPTION (provided by applicant): Robotic assisted laparoscopic (RAL) surgery continues to gain popularity among pediatric urologists, particularly for reconstructive procedures such as correction of ureteropelvic junction (UPJ) obstruction or vesicoureteral reflux (VUR). Despite impressive outcomes with traditional open approaches many pediatric urologists are shifting towards newer RAL approaches, claiming faster recovery and improved cosmesis with a nominal increase in surgical cost. To date, no randomized controlled trials exist in the pediatric population comparing robotic to open surgery. However, this is not unusual. Conducting a randomized controlled trial (RCT) of surgical interventions can be very difficult, especially in the pediatric population. One barrier frequently encountered is difficulty recruiting
patients and families to participate in a RCT involving surgical procedures. Many patients and their families do not wish treatment to be decided by chance, many families may be concerned that the doctor-patient relationship can be affected by participation in a RCT, or the parent may have feelings of personal responsibility if the treatments have unequal outcomes. In order to use RCTs to assess for treatment superiority, appropriate and meaningful patient-centered outcomes must first be identified and measured. Additionally, studies of pediatric robotic surgery have focused on traditional outcomes, e.g., length of stay, cost analysis, and capital gains benefits - important to healthcare professionals. While these measures are useful to study, we believe that researchers must also focus on patients' treatment experiences or patients' evaluations of their own outcomes. Our study will serve as a proof of concept trial to demonstrate the feasibility of (1) recruiting and randomizing pediatric patients into a study comparing surgical procedures and (2) delineating patient-centered outcomes. Should this study prove randomization is feasible, we 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. We will utilize novel patient-centered research methods to identify outcomes of importance to patients and families related to pediatric pyeloplasty, and determine patient and family preferences regarding acceptability of randomization and blinding of pediatric patients to construct a recruitment approach to achieve enrollment goals (Aim 1). We will then conduct a randomized pilot study with the goal of enrolling 10-20 pediatric patients aged 2 - 8 years to either open or robotic pyeloplasty for treatment of primary UPJ obstruction (Aim 2). We believe that our 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 and their families and simultaneously optimizes their willingness to participate in an RCT of a surgical intervention. These same innovative research methods will allow us to explore what outcomes are meaningful to patients and their families, allowing us to counsel patients and families to maximize their chances of achieving patient- and family-centered goals.
StatusFinished
Effective start/end date9/3/158/31/17

Funding

  • National Institutes of Health: $234,000.00

ASJC

  • Medicine(all)

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