Pediatric Robotic Versus Open Pyeloplasty

NCT04884945 | Terminated Results FDA Device

• 1 other identifier: 1403886306
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Urology; Ureteropelvic Junction Obstruction

Keywords

patient centered outcomes

Outcome Measures

Primary Outcomes (10)

• Length of Post Op Inpatient Hospital Stay Measured in Days

  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

  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)

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Robotic Surgery

ACTIVE COMPARATOR

Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction

Device: Robotic-Assisted Laparoscopic Pyeloplasty (RALP)

Open Surgery

ACTIVE COMPARATOR

Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction

Procedure: Open Pyeloplasty (OP)

Interventions

Open Pyeloplasty (OP) PROCEDURE

Open approach for the surgical correction of UPJ obstruction

Open Surgery

Robotic-Assisted Laparoscopic Pyeloplasty (RALP) DEVICE

Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction

Robotic Surgery

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation
• Patient between age 2 - 8 years old

You may not qualify if:

• Serious comorbidities (cardiovascular or respiratory disease, or other congenital anomalies requiring surgical intervention).
• BMI greater than the 95th %tile for age.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Riley Children's Hospital

Indianapolis, Indiana, 46201, United States

Location

Related Publications (52)

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MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Results Point of Contact

• Title: Stacy Keller
• Organization: Indiana University School of Medicine, Pediatrics

stasulli@iu.edu

3172786127

Study Officials

• Benjamin Whittam, MD

  Riley Children's Health, Indiana University Health, Pediatric Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient, Family, and Nursing Staff on Surgical Floor
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Urology

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: May 13, 2021
• Study Start: October 24, 2017
• Primary Completion: November 14, 2019
• Study Completion: June 23, 2021
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Locations

US (1)