An interventional study of Open Pyeloplasty (OP) and Robotic-Assisted Laparoscopic Pyeloplasty (RALP) in Pediatric Urology and Ureteropelvic Junction Obstruction, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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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.
Technological innovations are an ongoing reality in clinical medicine, most dramatically in the operating room. Each advance is often heralded as an improvement in patient care, promising to correct deficiencies and advance standard operative procedures. Unfortunately, these new technologies often lack sufficient evidence to support such claims. Robotic assisted laparoscopic (RAL) surgery continues to gain popularity among pediatric surgical specialists, particularly for reconstructive procedures such as correction of ureteropelvic junction (UPJ) obstruction or vesicoureteral reflux (VUR).In these operations, where traditional open surgery yields a nearly 95% clinical success rate it is difficult to demonstrate improvement with a new surgical technique. Despite these impressive outcomes with the open approach many pediatric urologists are shifting towards newer RAL approaches, claiming faster recovery and improved cosmesis with a nominal increase in surgical cost.
There is a striking dearth of comparative effectiveness research in pediatric surgical specialties, especially given the wide range of available therapies for a variety of surgical problems. Conducting randomized controlled trials of surgical interventions can be very difficult, especially in the pediatric population.
Currently, all studies of pediatric robotic surgery have focused on traditional outcomes, e.g., length of stay, pain scores, pain medication usage, scar perception, cost analysis, and capital gains benefits. While these measures are important to study, the investigators believe that researchers must also focus on patients' treatment experiences or patients' evaluations of their own outcomes. By focusing on these 'patient-centered outcomes' the investigators will be able to improve outcomes from surgical procedures in ways that are most important to patients and their families.
We propose 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, the investigators 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.
The investigators propose to accomplish these goals with the following Specific Aims:
Aim 1: Utilize novel patient-centered research methods to:
Aim 2: Conduct a randomized pilot study with goal of enrolling ten to twenty pediatric patients (age 2 - 8 years) to either open or robotic pyeloplasty for treatment of primary UPJ obstruction.
Sub Aim 2a: Collect preliminary data regarding the patient-centered outcomes identified in Aim 1.
Sub Aim 2b: Evaluate the effectiveness of the recruitment approach for randomized surgical studies developed in Aim 1.
The investigators believe that the 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/families and optimizes participant willingness to participate in RCTs of surgical interventions. Additionally these same innovative research methods will allows the investigators to explore what outcomes are meaningful to patients and families, which will hopefully allow the care team to counsel patients and families in a way that maximizes their chances of achieving patient- and family-centered goals.
26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 20 interventional studies indexed under Multicystic renal dysplasia, bilateral.
Browse Multicystic renal dysplasia, bilateral studies →Indiana University is the lead sponsor of 988 studies on the registry; 200 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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For Aim 2:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction
Device: Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction
Procedure: Open Pyeloplasty (OP)
Open approach for the surgical correction of UPJ obstruction
Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction
Length of Post Op Inpatient Hospital Stay Measured in Days
Number of inpatient hospital days post surgery obtained via retrospective chart.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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).
Time frame: 3 month follow up visit
| Milestone | Robotic Surgery | Open Surgery |
|---|---|---|
| Started | 5 | 6 |
| 1 week post op | 5 | 6 |
| 2 week post op | 4 | 6 |
| 6 week post op | 4 | 6 |
| 3 month follow up | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 1 | 1 |
Number of inpatient hospital days post surgery obtained via retrospective chart.
| days | Robotic Surgery | Open Surgery |
|---|---|---|
| Length of Post Op Inpatient Hospital Stay Measured in Days | 1 ± 0 | 1 ± 0 |
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
| Number of Doses | Robotic Surgery | Open Surgery |
|---|---|---|
| Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op | 0.600 ± 0.550 | 0.500 ± 0.550 |
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
| MME | Robotic Surgery | Open Surgery |
|---|---|---|
| Total Dose of Narcotic Pain Medication In the First 24 Hours Post Op in Morphine Milligram Equivalents (MME) | 1.2 ± 1.10 | 0.500 ± 0.550 |
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
| grade on a scale | Robotic Surgery | Open Surgery |
|---|---|---|
| Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification | 0.6 ± 1.34 | 0 ± 0 |
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)
| score on a scale | Robotic Surgery | Open Surgery |
|---|---|---|
| Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up | 2.5 ± 3.70 | 0 ± 0 |
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.
| days | Robotic Surgery | Open Surgery |
|---|---|---|
| Length Of Time For Patient To Return To Normal Routine After Surgery Measured in Days at 2 Week Post Follow Up | 7.67 ± 5.03 | 6.5 ± 3.73 |
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.
| days | Robotic Surgery | Open Surgery |
|---|---|---|
| Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up | 3.33 ± 3.51 | 5 ± 3.92 |
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."
| score on a scale | Robotic Surgery | Open Surgery |
|---|---|---|
| Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit | 10.25 ± 3.86 | 11.40 ± 3.05 |
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.
| score on a scale | Robotic Surgery | Open Surgery |
|---|---|---|
| Satisfaction With Symptoms Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit | 5.50 ± 1 | 7 ± 2.74 |
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).
| score on a scale | Robotic Surgery | Open Surgery |
|---|---|---|
| Quality of Life Measured Using The Glasgow Children's Benefit Inventory at 3 Month Follow Up Visit | 14.08 ± 32.42 | 20.88 ± 31.86 |
Collected over 3yr 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic Surgery | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Open Surgery | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Customized(Participants) | Robotic Surgery | Open Surgery | Total |
|---|---|---|---|
| Age 2 to 8 years | 5 | 6 | 11 |
| Sex: Female, Male(Participants) | Robotic Surgery | Open Surgery | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 2 | 6 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Robotic Surgery | Open Surgery | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 3 | 8 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Region of Enrollment(participants) | Robotic Surgery | Open Surgery | Total |
|---|---|---|---|
| United States | 5 | 6 | 11 |
Ran from Oct 2017 to primary completion in Nov 2019, 24 months.
Results were first posted in Jun 2024, 4 years 6 months after primary completion.
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Multicystic renal dysplasia, bilateral →