MP71-02 THE RANDOMIZED ROBOT STUDY, A PILOT COMPARATIVE EFFECTIVENESS TRIAL FOR ROBOTIC ASSISTED LAPARASCOPIC VS. OPEN PYELOPLASTY IN CHILDREN

Abstract

You have accessJournal of UrologyPediatrics: Upper Urinary Tract Disorders and Fetal Urology (MP71)1 Apr 2020MP71-02 THE RANDOMIZED ROBOT STUDY, A PILOT COMPARATIVE EFFECTIVENESS TRIAL FOR ROBOTIC ASSISTED LAPARASCOPIC VS. OPEN PYELOPLASTY IN CHILDREN William Bennett, Konrad Szymanski, Mark Cain, Rosalie Misseri, and Benjamin Whittam* William BennettWilliam Bennett More articles by this author , Konrad SzymanskiKonrad Szymanski More articles by this author , Mark CainMark Cain More articles by this author , Rosalie MisseriRosalie Misseri More articles by this author , and Benjamin Whittam*Benjamin Whittam* More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000951.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Robotic assisted laparoscopic (RAL) surgery continues to gain popularity among pediatric urologists, particularly for reconstructive procedures such as correction of ureteropelvic junction obstruction (UPJO). Since traditional open surgery yields a nearly 95% clinical success rate, it is difficult to determine which approach is most advantageous to patients. Despite excellent clinical outcomes with the open approach, many pediatric urologists are shifting towards newer RAL approaches, claiming faster recoveryand improved cosmesiswith a nominal increase in surgical cost in the absence of randomized controlled trials (RCTs). We designed a pilot comparative effectiveness trial of open versus robotic pyeloplasty in pediatric patients. METHODS: Non-obese (<95th% BMI for age) patients age 2 – 8 years old diagnosed with a UPJO were approached by a research assistant regarding enrollment into the RCT. Upon signing consent, patients were randomized to OP or RALP and scheduled for surgery. The surgical team was blinded as to the randomization assignment until the morning of the scheduled operation. Intraoperatively, patients underwent cystoscopy, retrograde pyelogram and retrograde stent placement with extraction string, then underwent either open or robotic pyeloplasty with a similar transversalis plane block by anesthesia and the same dressings were applied. Patients, families and nursing staff were blinded as to the approach used for the first 24 hours postoperatively. We then assessed our primary outcomes of pain scores with each nursing assessment, total length of stay. RESULTS: (91%): 5 underwent open pyeloplasty and 5 robotic pyeloplasty. All patients were symptomatic with flank pain and associated nausea/vomiting. Mean age was 5.4 years, 7 were male, and had an average BMI of 16.7kg/m2. UPJO was right-sided in 4 patients (with one solitary kidney). On exit interview at 24 hours post surgery, blinding was deemed adequate by families and nursing staff, with only 40% correctly identifying the procedure. There were no intraoperative complication and one 30 day Clavien 3b complication (a stent removal in the operating room). At last follow-up, all patients remained asymptomatic with stable or improved hydronephrosis. CONCLUSIONS: We successfully randomized and blinded 10 children to undergo either open or robotic surgery. Using current recruitment strategy and expanding inclusion criteria, we are planning a multi-institutional comparative effectiveness trial comparing open to robotic pyeloplasty in the pediatric population. Source of Funding: NIH: 1R21DK108134-01 © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1064-e1064 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information William Bennett More articles by this author Konrad Szymanski More articles by this author Mark Cain More articles by this author Rosalie Misseri More articles by this author Benjamin Whittam* More articles by this author Expand All Advertisement PDF downloadLoading ...