Trial Outcomes & Findings for Pediatric Robotic Versus Open Pyeloplasty (NCT NCT04884945)

NCT ID: NCT04884945

Last Updated: 2024-06-06

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: surgery to discharge
• Results posted on: 2024-06-06

Participant Flow

Participant milestones

Measure	Robotic Surgery Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): 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 Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Overall Study STARTED	5	6
Overall Study 1 Week Post op	5	6
Overall Study 2 Week Post op	4	6
Overall Study 6 Week Post op	4	6
Overall Study 3 Month Follow up	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Robotic Versus Open Pyeloplasty

Baseline characteristics by cohort

Measure	Robotic Surgery n=5 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction	Total n=11 Participants Total of all reporting groups
Age, Customized Age 2 to 8 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: surgery to discharge

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

Outcome measures

Measure	Robotic Surgery n=5 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Length of Post Op Inpatient Hospital Stay Measured in Days	1 days Standard Deviation 0	1 days Standard Deviation 0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Robotic Surgery n=5 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op	0.600 Number of Doses Standard Deviation 0.550	0.500 Number of Doses Standard Deviation 0.550

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Robotic Surgery n=5 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Total Dose of Narcotic Pain Medication In the First 24 Hours Post Op in Morphine Milligram Equivalents (MME)	1.2 MME Standard Deviation 1.10	0.500 MME Standard Deviation 0.550

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Robotic Surgery n=5 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification	0.6 grade on a scale Standard Deviation 1.34	0 grade on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 1 week post op follow up

Population: FLACC scores 2 week post op

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)

Outcome measures

Measure	Robotic Surgery n=4 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=5 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up	2.5 score on a scale Standard Deviation 3.70	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 2 week post op follow up

Population: Participant asked "At this point in your child's post op recovery, has your home routine returned to normal?" If participant responded "Yes" then participant asked "Estimate the length of time length of time it took to return to normal."

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.

Outcome measures

Measure	Robotic Surgery n=3 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=6 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Length Of Time For Patient To Return To Normal Routine After Surgery Measured in Days at 2 Week Post Follow Up	7.67 days Standard Deviation 5.03	6.5 days Standard Deviation 3.73

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Robotic Surgery n=3 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=4 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up	3.33 days Standard Deviation 3.51	5 days Standard Deviation 3.92

PRIMARY outcome

Timeframe: up to 3 month follow up visit (18 weeks post op)

Population: Satisfaction with Appearance at 3 month follow up

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."

Outcome measures

Measure	Robotic Surgery n=4 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=5 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit	10.25 score on a scale Standard Deviation 3.86	11.40 score on a scale Standard Deviation 3.05

PRIMARY outcome

Timeframe: up to 3 month follow up visit (18 weeks post op)

Population: Satisfaction with Appearance at 3 month follow up

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.

Outcome measures

Measure	Robotic Surgery n=4 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=5 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Satisfaction With Symptoms Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit	5.50 score on a scale Standard Deviation 1	7 score on a scale Standard Deviation 2.74

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Robotic Surgery n=4 Participants Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Robotic-Assisted Laparoscopic Pyeloplasty (RALP): Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction	Open Surgery n=5 Participants Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction
Quality of Life Measured Using The Glasgow Children's Benefit Inventory at 3 Month Follow Up Visit	14.08 score on a scale Standard Deviation 32.42	20.88 score on a scale Standard Deviation 31.86

Adverse Events

Robotic Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stacy Keller

Indiana University School of Medicine, Pediatrics

Phone: 3172786127

Email: stasulli@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place