Pediatric UrologyNCT04884945
Pediatric Robotic Versus Open Pyeloplasty
A study testing Open Pyeloplasty (OP) and Robotic-Assisted Laparoscopic Pyeloplasty (RALP) in people with Pediatric Urology and Ureteropelvic Junction Obstruction, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Pediatric Urology, Ureteropelvic Junction Obstruction
- What is being tested?
- Open Pyeloplasty (OP) and Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation
- Patient between age 2 - 8 years old
Who cannot join
- Serious comorbidities (cardiovascular or respiratory disease, or other congenital anomalies requiring surgical intervention).
- BMI greater than the 95th %tile for age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Children's Hospital
Indianapolis, Indiana, 46201
About this study
Official title: Pediatric Robotic Versus Open Pyeloplasty: A Pilot Randomized Control Study
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.
Read the detailed description
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:
- Identify outcomes of importance to patients and families related to pediatric pyeloplasty.
- Determine patient and family preferences regarding acceptability of randomization and blinding of pediatric surgical patients and construct a recruitment approach to achieve enrollment.
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.
- Being tested
- Open Pyeloplasty (OP), Robotic-Assisted Laparoscopic Pyeloplasty (RALP)
- Keywords
- patient centered outcomes
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Pyeloplasty (OP)Procedure or surgery
Open approach for the surgical correction of UPJ obstruction
Robotic-Assisted Laparoscopic Pyeloplasty (RALP)Device
Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction
| Study group | Role | What they receive |
|---|---|---|
| Robotic Surgery | Active comparator | Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction Receives: Device: Robotic-Assisted Laparoscopic Pyeloplasty (RALP) |
| Open Surgery | Active comparator | Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction Receives: Procedure: Open Pyeloplasty (OP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Post Op Inpatient Hospital Stay Measured in Days
Number of inpatient hospital days post surgery obtained via retrospective chart.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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).
Measured: 3 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start24 Oct 2017
- Primary completion14 Nov 2019
- Study completion23 Jun 2021
Why it stopped: Unable to resume recruitment post COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Pediatric UrologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Whittam, Indiana University
- Investigators
- Benjamin Whittam, MD, Principal investigator, Riley Children's Health, Indiana University Health, Pediatric Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884945
- Sponsor's protocol ID
- 1403886306
- Status last verified
- May 2024
- First submitted
- 10 Nov 2020
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 23522294Liu 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.
PubMed 25082711Steffens J, Langen PH, Haben B, Hiebl R, Steffens L, Polsky MS. Politano-leadbetter ureteroneocystostomy. A 30-year experience. Urol Int. 2000;65(1):9-14. doi: 10.1159/000064827.
PubMed 10965295Shaul DB, Cunningham JA, Lowe P, Skaist LB, Hardy BE. Infant pyeloplasty is a low-risk procedure. J Pediatr Surg. 1994 Feb;29(2):343-7. doi: 10.1016/0022-3468(94)90345-x.
PubMed 8176617Hendren WH, Radhakrishnan J, Middleton AW Jr. Pediatric pyleoplasty. J Pediatr Surg. 1980 Apr;15(2):133-44. doi: 10.1016/s0022-3468(80)80004-2.
PubMed 7373488Salem YH, Majd M, Rushton HG, Belman AB. Outcome analysis of pediatric pyeloplasty as a function of patient age, presentation and differential renal function. J Urol. 1995 Nov;154(5):1889-93.
PubMed 7563377Behan JW, Kim SS, Dorey F, De Filippo RE, Chang AY, Hardy BE, Koh CJ. Human capital gains associated with robotic assisted laparoscopic pyeloplasty in children compared to open pyeloplasty. J Urol. 2011 Oct;186(4 Suppl):1663-7. doi: 10.1016/j.juro.2011.04.019.
PubMed 21862079Lee RS, Retik AB, Borer JG, Peters CA. Pediatric robot assisted laparoscopic dismembered pyeloplasty: comparison with a cohort of open surgery. J Urol. 2006 Feb;175(2):683-7; discussion 687. doi: 10.1016/S0022-5347(05)00183-7.
PubMed 16407025Cundy TP, Harling L, Hughes-Hallett A, Mayer EK, Najmaldin AS, Athanasiou T, Yang GZ, Darzi A. Meta-analysis of robot-assisted vs conventional laparoscopic and open pyeloplasty in children. BJU Int. 2014 Oct;114(4):582-94. doi: 10.1111/bju.12683.
PubMed 25383399Barbosa JA, Barayan G, Gridley CM, Sanchez DC, Passerotti CC, Houck CS, Nguyen HT. Parent and patient perceptions of robotic vs open urological surgery scars in children. J Urol. 2013 Jul;190(1):244-50. doi: 10.1016/j.juro.2012.12.060. Epub 2012 Dec 28.
PubMed 23276511Bennett WE Jr, Whittam BM, Szymanski KM, Rink RC, Cain MP, Carroll AE. Validated cost comparison of open vs. robotic pyeloplasty in American children's hospitals. J Robot Surg. 2017 Jun;11(2):201-206. doi: 10.1007/s11701-016-0645-1. Epub 2016 Oct 20.
PubMed 27766551Ferreira LM. Surgical randomized controlled trials: reflection of the difficulties. Acta Cirurgica Brasileira 2005;19(Suppl 1):2-3.
McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002 Jun 15;324(7351):1448-51. doi: 10.1136/bmj.324.7351.1448. No abstract available.
PubMed 12065273Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004 Aug 28-Sep 3;364(9436):803-11. doi: 10.1016/S0140-6736(04)16942-0.
PubMed 15337409Curry JI, Reeves B, Stringer MD. Randomized controlled trials in pediatric surgery: could we do better? J Pediatr Surg. 2003 Apr;38(4):556-9. doi: 10.1053/jpsu.2003.50121.
PubMed 12677565
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Robotic Versus Open Pyeloplasty: A Pilot Randomized Control Study
- ClinicalTrials.gov ID
- NCT04884945
- Acronym / sponsor ID
- 1403886306
- Keywords
- patient centered outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to resume recruitment post COVID.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Identify outcomes of importance to patients and families related to pediatric pyeloplasty.
- Determine patient and family preferences regarding acceptability of randomization and blinding of pediatric surgical patients and construct a recruitment approach to achieve enrollment.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robotic Surgery | Active comparator | Device: Robotic-Assisted Laparoscopic Pyeloplasty (RALP)Robotic-Assisted Laparoscopic Pyeloplasty (RALP), standard of care treatment option for UPJ obstruction |
| Open Surgery | Active comparator | Procedure: Open Pyeloplasty (OP)Open Pyeloplasty (OP), standard of care treatment option for UPJ obstruction |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary UPJ obstruction diagnosed by scan and presenting to the pediatric urology clinic for evaluation
- Patient between age 2 - 8 years old
Key exclusion criteria (2 listed)
- Serious comorbidities (cardiovascular or respiratory disease, or other congenital anomalies requiring surgical intervention).
- BMI greater than the 95th %tile for age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Pyeloplasty (OP)Open approach for the surgical correction of UPJ obstruction | Procedure or surgery | Open Surgery |
| Robotic-Assisted Laparoscopic Pyeloplasty (RALP)Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction | Device | Robotic Surgery |
Primary outcome
Length of Post Op Inpatient Hospital Stay Measured in Days
Time frame: surgery to discharge
Number of inpatient hospital days post surgery obtained via retrospective chart.
Number of Doses of Narcotic Pain Medication In the First 24 Hours Post Op
Time frame: 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
Total Dose of Narcotic Pain Medication In the First 24 Hours Post Op in Morphine Milligram Equivalents (MME)
Time frame: 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
Grade of Surgical Complications up to 1 Year Post op Using Clavian-Dindo Classification
Time frame: 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
Pain Score Measured Using The FLACC at 2 Week Post Op Follow Up
Time frame: 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)
Length Of Time For Patient To Return To Normal Routine After Surgery Measured in Days at 2 Week Post Follow Up
Time frame: 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.
Length Of Time Parent Was Out Of Work After Child's Surgery Measured in Days at 2 Week Post Follow Up
Time frame: 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.
Satisfaction With Scar Appearance Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit
Time frame: 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."
Satisfaction With Symptoms Measured Using the Patient Scar Assessment Questionnaire at 3 Month Follow Up Visit
Time frame: 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.
Quality of Life Measured Using The Glasgow Children's Benefit Inventory at 3 Month Follow Up Visit
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23522294Monn 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.
- Background: PubMed 25082711Liu 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.
- Background: PubMed 10965295Steffens J, Langen PH, Haben B, Hiebl R, Steffens L, Polsky MS. Politano-leadbetter ureteroneocystostomy. A 30-year experience. Urol Int. 2000;65(1):9-14. doi: 10.1159/000064827.
- Background: PubMed 8176617Shaul DB, Cunningham JA, Lowe P, Skaist LB, Hardy BE. Infant pyeloplasty is a low-risk procedure. J Pediatr Surg. 1994 Feb;29(2):343-7. doi: 10.1016/0022-3468(94)90345-x.
- Background: PubMed 7373488Hendren WH, Radhakrishnan J, Middleton AW Jr. Pediatric pyleoplasty. J Pediatr Surg. 1980 Apr;15(2):133-44. doi: 10.1016/s0022-3468(80)80004-2.
- Background: PubMed 7563377Salem YH, Majd M, Rushton HG, Belman AB. Outcome analysis of pediatric pyeloplasty as a function of patient age, presentation and differential renal function. J Urol. 1995 Nov;154(5):1889-93.
- Background: PubMed 21862079Behan JW, Kim SS, Dorey F, De Filippo RE, Chang AY, Hardy BE, Koh CJ. Human capital gains associated with robotic assisted laparoscopic pyeloplasty in children compared to open pyeloplasty. J Urol. 2011 Oct;186(4 Suppl):1663-7. doi: 10.1016/j.juro.2011.04.019.
- Background: PubMed 16407025Lee RS, Retik AB, Borer JG, Peters CA. Pediatric robot assisted laparoscopic dismembered pyeloplasty: comparison with a cohort of open surgery. J Urol. 2006 Feb;175(2):683-7; discussion 687. doi: 10.1016/S0022-5347(05)00183-7.
- Background: PubMed 25383399Cundy TP, Harling L, Hughes-Hallett A, Mayer EK, Najmaldin AS, Athanasiou T, Yang GZ, Darzi A. Meta-analysis of robot-assisted vs conventional laparoscopic and open pyeloplasty in children. BJU Int. 2014 Oct;114(4):582-94. doi: 10.1111/bju.12683.
- Background: PubMed 23276511Barbosa JA, Barayan G, Gridley CM, Sanchez DC, Passerotti CC, Houck CS, Nguyen HT. Parent and patient perceptions of robotic vs open urological surgery scars in children. J Urol. 2013 Jul;190(1):244-50. doi: 10.1016/j.juro.2012.12.060. Epub 2012 Dec 28.
- Background: PubMed 27766551Bennett WE Jr, Whittam BM, Szymanski KM, Rink RC, Cain MP, Carroll AE. Validated cost comparison of open vs. robotic pyeloplasty in American children's hospitals. J Robot Surg. 2017 Jun;11(2):201-206. doi: 10.1007/s11701-016-0645-1. Epub 2016 Oct 20.
- BackgroundFerreira LM. Surgical randomized controlled trials: reflection of the difficulties. Acta Cirurgica Brasileira 2005;19(Suppl 1):2-3.
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Not yet recruitingPhase 3
Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
Endothelial Dysfunction, End-Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Whittam, MD principal investigator
Riley Children's Health, Indiana University Health, Pediatric Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Pyeloplasty (OP) and Robotic-Assisted Laparoscopic Pyeloplasty (RALP) in people with Pediatric Urology and Ureteropelvic Junction Obstruction, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Post Op Inpatient Hospital Stay Measured in Days (time frame: surgery to discharge). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884945, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.