NCT04884945

Pediatric Robotic Versus Open Pyeloplasty

Terminated NA Results posted Last updated 6 June 2024

What this trial tests

NA trial testing Open Pyeloplasty (OP) in Pediatric Urology in 11 participants. Terminated before completion.

Timeline

24 October 2017

Primary endpoint
14 November 2019

23 June 2021

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	11
Start date	24 October 2017
Primary completion	14 November 2019
Estimated completion	23 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Open Pyeloplasty (OP)
• Robotic-Assisted Laparoscopic Pyeloplasty (RALP)

Conditions studied

• Pediatric Urology — all drugs for Pediatric Urology →
• Ureteropelvic Junction Obstruction — all drugs for Ureteropelvic Junction Obstruction →

Sponsor

Indiana University

Who can join

Adults 2 to 8, any sex, with Pediatric Urology or Ureteropelvic Junction Obstruction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Post Op Inpatient Hospital Stay Measured in Days Primary · surgery to discharge

Number of inpatient hospital days post surgery obtained via retrospective chart.

Group	Value	95% CI
Robotic Surgery	1	± 0
Open Surgery	1	± 0

Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op Primary · 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

Group	Value	95% CI
Robotic Surgery	0.600	± 0.550
Open Surgery	0.500	± 0.550

Total Dose of Narcotic Pain Medication In the First 24 Hours Post Op in Morphine Milligram Equivalents (MME) Primary · 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

Group	Value	95% CI
Robotic Surgery	1.2	± 1.10
Open Surgery	0.500	± 0.550

Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification Primary · 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.

Group	Value	95% CI
Robotic Surgery	0.6	± 1.34
Open Surgery	0	± 0

Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up Primary · 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)

Group	Value	95% CI
Robotic Surgery	2.5	± 3.70
Open Surgery	0	± 0

Length Of Time For Patient To Return To Normal Routine After Surgery Measured in Days at 2 Week Post Follow Up Primary · 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.

Group	Value	95% CI
Robotic Surgery	7.67	± 5.03
Open Surgery	6.5	± 3.73

Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up Primary · 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.

Group	Value	95% CI
Robotic Surgery	3.33	± 3.51
Open Surgery	5	± 3.92

Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit Primary · 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."

Group	Value	95% CI
Robotic Surgery	10.25	± 3.86
Open Surgery	11.40	± 3.05

Satisfaction With Symptoms Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit Primary · 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.

Group	Value	95% CI
Robotic Surgery	5.50	± 1
Open Surgery	7	± 2.74

Quality of Life Measured Using The Glasgow Children's Benefit Inventory at 3 Month Follow Up Visit Primary · 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).

Group	Value	95% CI
Robotic Surgery	14.08	± 32.42
Open Surgery	20.88	± 31.86

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.