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Unable to resume recruitment post COVID.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Surgery | Active Comparator | Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction |
|
| Open Surgery | Active Comparator | Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Pyeloplasty (OP) | Procedure | Open approach for the surgical correction of UPJ obstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For Aim 2:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Whittam, MD | Riley Children's Health, Indiana University Health, Pediatric Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Children's Hospital | Indianapolis | Indiana | 46201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23522294 | Background | Monn MF, Bahler CD, Schneider EB, Whittam BM, Misseri R, Rink RC, Sundaram CP. Trends in robot-assisted laparoscopic pyeloplasty in pediatric patients. Urology. 2013 Jun;81(6):1336-41. doi: 10.1016/j.urology.2013.01.025. Epub 2013 Mar 19. | |
| 25082711 | Background | Liu DB, Ellimoottil C, Flum AS, Casey JT, Gong EM. Contemporary national comparison of open, laparoscopic, and robotic-assisted laparoscopic pediatric pyeloplasty. J Pediatr Urol. 2014 Aug;10(4):610-5. doi: 10.1016/j.jpurol.2014.06.010. Epub 2014 Jul 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Open Surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Post Op Inpatient Hospital Stay Measured in Days | Number of inpatient hospital days post surgery obtained via retrospective chart. | Posted | Mean | Standard Deviation | days | surgery to discharge |
|
3yr 8 months
Study start (10.24.17) to Study end (6.23.21)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacy Keller | Indiana University School of Medicine, Pediatrics | 3172786127 | stasulli@iu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2018 | May 6, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C537373 | Multicystic renal dysplasia, bilateral |
Not provided
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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.
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Patient, Family, and Nursing Staff on Surgical Floor
| Robotic-Assisted Laparoscopic Pyeloplasty (RALP) | Device | Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction |
|
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 |
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Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Open Pyeloplasty (OP): Open approach for the surgical correction of UPJ obstruction |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | Number of Doses | Surgery to the first 24 hours post op |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | MME | Surgery to the first 24 hours post op |
|
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| Primary | 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 | Posted | Mean | Standard Deviation | grade on a scale | up to 1 year post up |
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| Primary | 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) | FLACC scores 2 week post op | Posted | Mean | Standard Deviation | score on a scale | 1 week post op follow up |
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| Primary | 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. | 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." | Posted | Mean | Standard Deviation | days | 2 week post op follow up |
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| Primary | 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. | Posted | Mean | Standard Deviation | days | 2 week post op follow up |
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| Primary | 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." | Satisfaction with Appearance at 3 month follow up | Posted | Mean | Standard Deviation | score on a scale | up to 3 month follow up visit (18 weeks post op) |
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| Primary | 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. | Satisfaction with Appearance at 3 month follow up | Posted | Mean | Standard Deviation | score on a scale | up to 3 month follow up visit (18 weeks post op) |
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up visit |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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