Pediatric Robotic Versus Open Pyeloplasty: A Pilot Randomized Control Study
Phase: NA
Conditions: Pediatric Urology, Ureteropelvic Junction Obstruction
Sponsor: Indiana University

Version Date 1.11.18 
 
Pediatric Robotic versus Open Pyeloplasty: A Pilot Randomized 
Control Study 
Pediatric Robotic versus Open Pyeloplasty: A Pilot Randomized Control 
Study 
 
Benjamin Whittam, MD 
 
 
Protocol ID  1403886306 
 
ClinicalTrials.gov ID NCT04884945 
 
 

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Specific Aims 
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).1,2 In these operations, where traditional open surgery 
yields a nearly 95% clinical success rate,3-6 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 recovery7-9 and improved cosmesis10 with a nominal increase 
in surgical cost.11 To date, no randomized controlled trials exist in the pediatric population comparing robotic to 
open surgery.  However, this is not unusual.  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 trails of surgical interventions can be very difficult, especially in 
the pediatric population.  One barrier frequently encountered is difficulty recruiting patients and families to 
participate in a randomized controlled trial (RCT) that involves surgical procedures.12-16 Patients and their 
families often reject RCTs, because they do not wish treatment to be decided by chance, the family is 
concerned that the doctor-patient relationship is affected by participation in a RCT, or the parent may have 
feelings of personal responsibility if the treatments are unequal.12-14 In order to use RCTs to determine 
treatment superiority, appropriate and meaningful outcomes must be identified and measured. 
 
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.7,8,10,17-19 While 
these measures are important to study, we believe that researchers must also focus on patients’ treatment 
experiences or patients’ evaluations of their own outcomes.  By focusing on these ‘patient-centered outcomes’ 
we will be able to improve outcomes from surgical procedures in ways that are most important to patients and 
their families.20 The field of urology has a tradition of patient engagement in surgical outcomes,18,21,22 but in 
general, patient and family input into outcomes measured in surgical clinical trials has been sparse. 
 
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, we 
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.   
 
We 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. 
 
We believe that our 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 their willingness to participate in RCTs of surgical interventions.  Additionally these same innovative 
research methods will allows us to explore what outcomes are meaningful to patients and their families, which 

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will hopefully allow us to counsel patients and families in a way that maximizes their chances of achieving 
patient- and family-centered goals. 
 
A. 
Significance 
 
A.1.  Congenital Ureteropelvic Junction (UPJ) Obstruction 
Ureteropelvic Junction (UPJ) obstruction is a common diagnosis in pediatric urology, occurring in 1 in 500 
births, and requires surgical correction in one third of cases.23  UPJ obstruction is characterized by impaired 
urine flow from the renal pelvis into the proximal ureter, resulting in dilation of the collection system and 
potential renal damage. Intrinsic UPJ obstruction stems from any combination of narrowing or kinking of the 
ureter, and congenital abnormalities of the ureteral wall or lumen, which then results in poor urine flow across 
the UPJ.  Intrinsic UPJ obstruction is flow-dependent – once a threshold flow is reached, an obstruction is 
induced. Extrinsic UPJ usually results from anomalous vasculature of the lower kidney, which causes proximal 
ureteral compression, resulting in intermittent obstruction.   
 
A.2. Treatment Options for UPJ Obstruction 
The three treatment options for UPJ Obstruction are described below: 
 
A.2.1 Open Pyeloplasty (OP) – Traditionally considered the gold standard for treatment of UPJ obstruction, OP 
has a success rate ranging from 90 – 100%.24,25 This approach requires a flank incision ranging from 2 to 6 cm 
in length in children. The renal pelvis and ureter are dismembered; the obstructive segment is usually excised 
and reconstructed to create a funneling into the ureter.  Patients are hospitalized for 1 – 2 days and are 
discharged with an external catheter or an internal ureteral stent. 
 
A.2.2 Laparoscopic Pyeloplasty (LP) – This minimally invasive technique utilizes the same principles as OP, 
but is performed intracorporally using trocars and laparoscopic instruments.  Usually three or four separate, 
small incisions (~1 cm) are used.  Long-term success rates have been shown to be identical to OP with similar 
costs; however, patients usually experience shorter hospitalization, but longer operative times.17,20,26-29 Patients 
are hospitalized typically for 1 day and discharged home with either an external catheter or internal ureteral 
stent as in OP. LP has failed to be widely adopted because of the high technical demand and steep learning 
curve, especially in pediatric patients who have decreased operative working space.   
 
A.2.3 Robotic-Assisted Laparoscopic Pyeloplasty (RALP) – RALP is an extrapolation and advancement of LP, 
providing a solution to the technical demands and steep learning curve of LP.30-32 RALP provides a 3D, 
magnified image, with increased instrument freedom and articulation.  The surgeon sits at a console and his 
movements are transmitted to the intracorporal robotic arms.  Three or four small incisions are utilized to place 
the robotic arms, all less than 1.0 cm.  Rather than placing the in incision on the flank, as is done with OP, 
RALP incisions can be concealed in the umbilicus and on the lower abdomen.  These patients are typically 
discharged the day after surgery with an internal ureteral stent. Robotic surgery has revolutionized the surgical 
landscape, offering the ability to perform increasingly complex operations through a minimally invasive 
approach without the significant learning curve associated with a pure laparoscopic surgical approach.30-33 In 
fact, recent data show decreased utilization of LP, as RALP becomes more common.1,34  
 
A.3.  Standard of Care: Robotic vs. Open Pyeloplasty 
In adults, a robotic approach has become the standard of care; however, in children a dichotomy exists.  At 
some institutions, children as young as 6 months35,36 undergo a robotic procedure, while at other institutions, 
children as old as 18 years old still have open procedures.1,2,34 Few studies comparing pediatric RALP and OP 
clinical outcomes exist; none are randomized. However, the following has been shown: 
• 
Current literature suggests long-term outcomes between RALP and OP are equivalent.8  
• 
RALP patients require less pain medication compared with OP.8,37   
• 
Nearly two-thirds of families would prefer robotic surgery scars.10  
• 
Shorter mean hospitalization for RALP, typically by an entire day (2.3 vs. 3.5 days, respectively).8   
 
No clear consensus exists as to whether robotic or open pyeloplasty should be the standard of care. The only 
way to resolve this issue is to conduct a randomized controlled trial in which outcomes that matter to both 
patients and surgeons are considered. However, two clear issues must be overcome in order to succeed. First, 

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we need to determine what measures and outcomes truly matter to patients, as well as physicians. Second, we 
need to insure that the many factors that have impeded prior RCTs of surgical procedures are overcome. 
 
A.4  Patient-Centered Outcome Measures 
Studies of surgical procedures have tended to focus on clinical outcomes (e.g., length of stay, pain control, 
complications). While these types of ‘traditional measures’ are clinically important to ensure safety and efficacy 
of surgical procedures,38 they do not always take into account the perspective of the patient or family. 
Research has demonstrated that patient experience and clinical quality/outcomes are distinct entities.39 We 
believe that researchers must pay attention to patients’ treatment experiences or patients’ evaluations of their 
own outcomes.  By focusing on these ‘patient-centered outcomes,’ we will be able to improve outcomes from 
surgical procedures in ways that are most important to patients and their families.20  
 
In the field of urology there has been sparse attention to patient- and family-centered outcomes in clinical 
trials.For example, studies of RALP have mostly used generic research instruments to assess preoperative 
and postoperative quality of life and scar perception after open and robotic pyeloplasty.10,40 While these studies 
provide useful data, they lack patient and family input into the creation of these research instruments and 
identification of outcomes that are meaningful to the patients and their families. In order to conduct an 
accurate, useful comparative effectiveness study aimed at determining which surgical modality is superior for 
treatment of pediatric UPJ obstruction, we must identify and collect data on patient/family-- outcomes.   
 
A.5.  Difficulties of Conducting Randomized Controlled Trials in Surgery  
There are few RCTs comparing surgical techniques in pediatric surgery 41 as these studies can be difficult to 
conduct in the pediatric population.42 One barrier frequently encountered is the challenge of recruiting 
patients.12-16 Surgical RCTs are often discontinued early due to slow or poor recruitment.43 Patients and 
families often reject RCTs because they do not wish treatment to be decided by chance, they have a 
preference regarding which procedure they want performed, they may be concerned that the doctor-patient 
relationship could be affected by participation in the study, or the parent may have feelings of personal 
responsibility if the treatments were found to be unequal.12-14   
 
B. Innovation 
This study will help us to overcome the barriers identified in Section A, to conduct a proof of concept trial to 
demonstrate feasibility of randomization, delineate patient-centered outcome measures, and provide the 
framework for a large randomized controlled trial comparing robotic and open techniques for surgical correction 
of congenital UPJ obstruction (pyeloplasty) in non-obese pediatric patients.   
 
The first area of innovation in this proposal is our use of innovative and novel patient-centered research 
methods will lead to significant breakthroughs in developing a recruitment approach that is both acceptable to 
pediatric patients and their families and also optimizes their willingness to participate in randomized controlled 
trials of surgical interventions (Aim 1 and Aim 2b).  Additionally, these same innovative research methods will 
allow us to explore which outcomes are meaningful to patients and their families, which will aid us in advising 
them in ways that maximize their chances of achieving patient- and family-centered goals (Aim 1 and Aim 2a).  
To accomplish these aims, our study will make use of the Pediatric Patient Engagement Research Core (PEC), 
which is a resource unique to our institution.   
 
PEC is supported by the IU Center for Pediatric and Adolescent Comparative Effectiveness Research 
(PACER) and Indiana CTSI Community Health Engagement Program. The PEC team offers services to 
academic researchers related to patient-centered outcome measurement, recruitment, study acceptability, and 
protocol adherence.  Once the target study population is identified, researchers are often limited in their ability 
to approach and collaborate with the patient and family.  These factors are due, in part, to lack of patient and 
family involvement during the development and implementation phases of research protocols. The PEC team’s 
approach uses designers as research ‘translators’ to bridge communication gaps between investigators and 
patients.  This approach is truly innovative, and results in research protocols and interventions that are 
fundamentally patient-centered, because they are developed in partnership with the patients.  By utilizing 
visual communication design specialists as facilitators, we are able to foster a co-designing relationship 
between the study investigators and patients and their families.  Section C.2 will expand further on the 
innovative design research and visual sociology methodologies that will be utilized for our study.     

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The PEC team has been highly successful at using innovative patient-centered approaches with other 
researchers at our institution.  For example, the PEC team has previously worked on the Pearl Grlz, CLIC* 
(Communicating Life in Our Community/Communicando la vida en nuestra comunidad) and the Avondale 
Health Study 44 45.  In these projects the PEC team was able to utilize design research and visual sociology 
methodologies successfully to better engage patients in the research process.  They were able to achieve 
remarkable outcomes for these projects by overcoming barriers to patient recruitment, fostering enthusiasm for 
study participation, and increasing engagement in the studies themselves.   
 
The second area of innovation is in our urology department’s commitment and willingness to allow for the 
blinding of patients, families, and postoperative care team (floor nurses, medical assistants) to the type of 
operation that was performed (robotic or open pyeloplasty). See the attached letter of support for more details. 
The important of this cannot be minimized, as surgeons’ unwillingness to allow for randomization of procedures 
is one of the key reasons for the lack of such studies in the medical literature.46 However, given the 
seriousness of this issue, we still feel it is important to conduct a small feasibility study such as this before 
asking for funding for a larger, fully powered randomized controlled trial. 
 
All patients, regardless of approach, will have the same number of dressings placed strategically after the 
procedure to simulate both possible types of surgical incisions.47 Thus, we hope to create a 24-hour window, 
during which the patient, family, and nurses are blinded to the procedure.  If successful, this will significantly 
reduce bias created by knowledge of the operative approach.  This will not alter standard of care and all 
surgical incisions will be assessed prior to discharge by the surgeon, who will be aware of the actual procedure 
performed.  These techniques will also be novel, and have not been performed to this extent in other studies. 
 
C.  Approach 
Our study will serve to demonstrate feasibility of recruiting pediatric patients to participate in a randomized 
control trial for a surgical procedure, delineate patient-centered outcomes, and provide the framework for a 
large randomized controlled trial comparing robotic and open techniques for surgical correction of congenital 
UPJ obstruction (pyeloplasty) in non-obese pediatric patients.  Our study aims are as follows: 
 
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 
 
C.1 Aim 1 - Recruitment Approach and Identification of Patient/Family-Centered Outcomes  
In collaboration with the PEC, we propose to employ innovative patient-centered research approaches in order 
to identify that would be meaningful to parents/patients who are undergoing treatment of primary UPJ 
obstruction.  Secondly, we want to explore the acceptability of participation in a randomized clinical trial by this 
population and what factors might optimize their willingness to be participants.  We will explore which 
information parents wish to receive without being coercive or untruthful. We will also address appropriate 
compensation and other factors that might contribute to participation.  
 
Figure 1 details a process map for the work that will be performed for Aim 1 including the composition of the 
group, the focus and content of each group session, and the deliverables that each session informs.  
Specifically, we propose to conduct a total of 5 patient/parent advisory group sessions. Sessions 1,3,4, and 5 
each of which will be up to 4 hours in duration in order to address these two objectives (See Figure 1).  
Session 2 will be the only session that includes adolescents (aged 13 – 17). It will be a virtual session that 
involves video chats and messaging through an online password protected communication platform. The aim 
of this session will be to address measurement.  Session 1 will target parents/patients (ideally patients ages 6-
10 year old) who have undergone either OP (N=5 patients/parent pairs) or RALP (N=5 patients/parent pairs) 

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procedure within the last 12 months.  Session 1 will address both measurement and randomization 
acceptability.  The second session will address measurement only and include adolescents (ideally ages 13 -
17) who had either the OP (N=5 patients) or RALP (N=5 patients) procedure performed.  The third and fourth 
sessions will address randomization acceptability only and include parents of children 2-8 years old with no 
history of surgery.  All session participants will be recruited from the pediatric urology clinic at Riley Hospital for 
Children and through community outreach in and around Indianapolis, IN.  Healthy subjects for sessions 3 and 
4 will be recruited in the community via a recruitment flyer as well as through the INResearch database. 
Participants for session 4 will also be recruited through the Riley Hospital Pediatric Urology Clinic. These 
meetings will take place during Y1 of the grant.  Participants in the in-person sessions 1,3,4, and 5 will be 
compensated for their time at a rate of $20/hour. Participants in the session 4 clinic and non-clinic community 
interviews will receive $10 as the interview is expected to only take 30 minutes.  In addition, compensation will 
be provided for food, parking, and childcare if necessary for participants. Participants in session 2 will be 
compensated $10 for completion of video chat number 1, $5 for completion of each activity, $20 for video chat 
number 2, and $20 if all activities have been completed.  Participants will also have an opportunity to submit an 
additional audio recording activity for an additional $20.     
 
The PEC team consists of Sarah Wiehe (director and co-investigator), Helen Sanematsu (faculty at Herron 
School of Art + Design and visual communications design specialist), and two visual communications 
experts/designers.48 The PEC team will utilize innovative visual sociology and design research methods that 
are often used in public health communication and have been shown to be effective at delivering messages to 
their intended audiences.49 The visual communication specialist will employ hands-on creative workshops that 
provide insight into patient/parent experiences and facilitate ‘co-designing’ of interventions with input coming 
from both patient/parents and study investigators.48,50,51 
 
Sessions 1 and 2 will address measurement. For 
session 1, we propose a “rapid idea generation” 
activity in order to uncover insights into potential 
measures of importance to patients/parents such as: 
a) 100mph Thinking where session participants are 
prompted to generate as many answers as possible 
in a short period of time and then are asked to look 
for similarities within the results or, b) Mind-mapping 
where participants generate branching concepts from 
a provocative word (See Figure 1).  For example, 
with “100mph Thinking” we might give parents ten 
minutes to write simple phrases that answers this 
question “How could this surgery affect your child’s 
day to day experience in five years?” on a sticky 
note. The parent would be asked to fill out as many 
sticky notes as they can.  These notes are then 
posted and arranged into groups of like qualities. 
Parents are then asked to write a simple phrase that 
answers a follow-up question such as “How could 
this specific quality affect your child’s day to day 
experience in five years?” Once again they are asked 
to fill out as many sticky notes as they can. This is 
repeated for all evocative groups, or until everyone’s 
“creative juices” have dried up.  These results will help uncover concerns 
parents have that they might not have even known they had about these surgeries. For session 2, we propose 
using “remote elicitation” & “on-line discussion” to discover QOL factors affected by this surgery. To 
accomplish this, we will host an online session that involves uploading videos, answering questions, and two 
video chats through a password protected online communication platform (RedCap).  Video chats will be 
facilitated through Skype. Participants will be asked to respond to activities online and there will be a minimum 
of six activities presented. Examples of some activities include draw their scar, identify who sees their scar, 
Figure 1. Patient/Parent

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explain how they would support a friend nervous about surgery, describe moments they have thought about 
their scar, list five goals they would like to accomplish in the future, and describe what they remember about 
their surgical experience. These results will help uncover concerns patients have that they might not have even 
known they had about these surgeries. 
 
For the sessions that address randomization acceptability (Sessions 1, 3 and 4) we propose to utilize  
“interpretation” activities like Telephone Taboo where participants have to restate ‘research’ language in their 
own words while being forbidden from using a certain word or phrase, or “role-play” activities like Freaky 
Friday where participants assume the roles of research assistants and recruit each-other in different situations.   
 
Following these four sessions, the PEC team and study investigators will analyze the findings from each of the 
session in order to develop the following deliverables: 
 
1. Recommendations for measurement domains from parents’ perspective and from patients’ experiences 
into adolescence and how they map to those measures proposed for the pilot study in Aim 2. 
2. Recommendations and design for recruitment strategy to be piloted in Aim 2 including a) consent form, 
b) study information sheet, c) script to be used by the study facilitator to introduce the consent form and 
information sheet, and d) story boards for expanded communication/informational piece 
(website, video, app, etc.) 
 
The data gleaned from Aim 1 can also be used to increase the chance of success for a wide variety of 
subsequent studies in surgical specialties where comparative effectiveness research is necessary. 
 
C.2 Aim 2 - Randomized Pilot Study   
We will conduct a randomized pilot study of the OP versus RALP surgical technique with the goal of enrolling 
ten to twenty pediatric patients between the ages of 2 – 8 years who require treatment for primary UPJ 
obstruction.   We will collect preliminary data regarding the patient-centered outcomes identified in Aim 1 and 
we will also evaluate the effectiveness of the recruitment strategy that was developed in Aim 1. 
 
 
 
 
C.2.1 Study Inclusion/Exclusion Criteria   
 
Inclusion Criteria 
Exclusion Criteria 
• 
Primary UPJ obstruction diagnosed by scan and presenting 
to the pediatric urology clinic for evaluation 
• 
Patient between age 2 – 8 years old 
• 
Serious comorbidities (cardiovascular or respiratory disease, 
or other congenital anomalies requiring surgical 
intervention). 
• 
BMI greater than the 95th %tile for age. 
 
C.2.2 Patient Identification and Recruitment.  All participants will be recruited from the pediatric urology service 
at Riley Hospital for Children in Indianapolis, IN. We will identify pediatric patients with a UPJ obstruction 
requiring surgical intervention, using a double check system to avoid missing potential study subjects.  Our 
clinical schedulers or surgeons in clinic will identify all potential study patients and flag them for the study PIs 
or RAs to review patient history.  In addition, each week one of the study PIs (Whittam) will assess all new 
patient referrals to identify any additional potential study candidates.   
 
Once eligible patients are identified, they will be introduced to a member of the research team.  Following the 
recruitment strategy developed in Aim 1, the study team member will introduce the study to the patient/family 
including presenting the expanded communication/ information pieces, the recruitment video and brochure,  
that were developed for the pilot study.  If they agree, they will provide verbal consent and be shown the 
recruitment video. This strategy will include a general description of the different surgical modalities, as well as 
risks and benefits of each procedure.  Emphasis will be placed on the fact that both options are equivalent. If 
they decide to be on the study, they will be consented in clinic, randomized to the study, and asked to 
complete a brief questionnaire as to why they decided to participate.  During the enrollment process, the ICS 
and Assent (for the participant who is 7 years or older) will be reviewed verbally. Participants will be provided 
with a hard copy to read and time to ask questions. After signing the consent and assent, participants will be 
given a copy for their record. 

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If they decline they will be asked to complete a brief questionnaire as to why they decided not to participate.  
 
Figure 2 shows the potential recruitment paths when 
an eligible patient is approached to participate in the 
study.   The blue dotted line reflects those 
patients/families that agree to participate in the 
randomized pilot study.  The study RA will obtain 
informed consent from these families utilizing the 
documents designed in Study Aim 1.  The pink dotted 
line reflects those patients/parents who are NOT 
willing to participate in a randomized study.  
Following their decision NOT to participate in the 
randomized study, the study RA will ask these 
families if they would be willing to 1) participate in a group session with the PEC 
team regarding their decision not to participate in the randomized study (See Figure 1, Session #5 and Figure 
2) if they would be willing to allow our study team to collect data on the outcome measures being utilized for 
our study (See Section C.2.7).  These families would not be randomized, but instead would be allowed to 
decide for themselves which procedure they would like to have performed.  By utilizing this approach we are 
guaranteed to obtain useful data, even if we are unable to successfully implement a pilot randomized trial.   
 
C.2.3 Compensation. Study participants will be compensated for their participation per findings from Aim 1.  
Aim 2, families who agree to participate in the randomized pilot study will receive a parking voucher during 
their child’s hospitalization and subsequent follow-up appointments.  They will receive $25 dollars for the initial 
follow up visit at 2 weeks and $10 for each follow-up visits (6 weeks, 3 months, 9 months) for a total of $55 if 
they complete all the follow up visits. 
 
C.2.4 Patient Randomization Procedure  Once parent/guardians have signed informed consent, patients will be 
immediately randomized to either RALP or OP by using a pool of 20 cards of which 10 say “robotic surgery” 
and 10 say “open surgery.” Each patient will then have a card randomly picked for them, thus ensuring an 
equivalent number of patients in each arm of the study.  The attending surgeon for the patient will assist or 
perform the operation to maintain continuity of patient care.. A single robotic surgeon will be involved in all 
robotic procedures and one of four senior surgeons will be involved in any open procedure. 
 
C.2.5 Operative Intervention Each subject will have anesthetic induction and intubation.  All patients will 
undergo a cystoscopy (endoscopy of the bladder) and retrograde pyelogram (instillation of contrast into ureter 
and across the UPJ) to confirm diagnosis of UPJ obstruction.  An internal double j stent will be placed in the 
affected ureter (small, completely internal tube resting in the ureter held in place with curl in the kidney and 
bladder) and a bladder catheter placed.  A standardized regional anesthetic block will be performed regardless 
of surgical approach. The pain service will place the block and follow the patient for pain management post 
operatively. Either RALP or OP will then be performed.  Each patient will have standard anesthesia reversal 
and extubation. 
 
Upon completion of the procedure, dressings will be placed on all surgical incisions, as well as anticipated 
locations of where incisions would be for the other procedure.  Thus, all patients will have the same numbers of 
bandages (4) on all possible surgical sites, regardless of surgical approach.   
 
C.2.6 Postoperative Care The patient will be transferred to the surgical floor once all standard PACU criteria 
have been met.  All medication administration will be documented for postoperative pain.  A clear liquid diet will 
be initiated, and diet will be advanced as tolerated.  On postoperative day one (POD #1) the foley catheter will 
be removed and intravenous fluids will be stopped. All pain medication will be converted to an oral route with a 
plan for an early afternoon discharge if patient meets discharge criteria.  Discharge criteria includes tolerating a 
regular diet, pain controlled on oral medication, ambulating without assistance and voiding spontaneously. 
Patients are followed at 1 week, 2 weeks, and 6 weeks post op. Their subsequent follow up appointments (3 
months, 6 months,, and 12months) are from the time of  their prior visit. . 
 
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C.2.7 Measures.  The patient-centered outcome measures that will be utilized in this study have been informed 
by the work of Aim 1. The list of outcomes below is not an exhaustive one, but does serve to outline that has 
been affirmed by the work in Aim 1.   
 
Outcome Measure 
Interval 
How Obtained 
Length of Hospital Stay (days) 
Once, after discharge 
Chart review by RA 
Pain Medication Use (dose/freq) 
Once, after discharge 
Chart review by RA  
Surgical complications 
Once, after discharge 
Chart review by RA, Clavian-Dindo classification52 
Total Hospital Charges and Estimated 
Costs 
Once, after discharge and data 
deposited to PHIS database  
PHIS database will be queried for charge and cost 
data submitted by the hospital  
Pain Scores 
Every 4 hours while 
hospitalized 
1 and 2 week post op follow up 
Chart review by RA (hospitalization and post op 
follow up 
Patient Experience: Side effects of 
medication and impact; Experience of 
having a temporary ureteral stent   
4; Ease of removing stent; Return to 
activity; Financial burden reported by 
family  
 
 
2 week post op follow up 
REDCAp survey or at time of 2 week post op follow 
up 
Time until parental return to work  
2 week post op follow up 
REDCAp survey or at time of 2 week post op follow 
up 
Scar perception 
At hospital discharge, and at 
1,2, and 6  post op follow ups, 
and 3mo follow up scheduled 
at 6week follow up 
REDCap survey or at time of  post op follow ups, 
using the Patient Scar Assessment Questionnaire53 
(PSAQ) 
 
Quality of Life (post intervention) 
 
At hospital discharge, at 1  2, 
and 6  week post op follow ups 
,and 3 mo return visit 
scheduled at 6week follow up 
 
REDCap survey or at time of post op follow ups, 
using the Glasgow Children’s Benefit 
Inventory  (GCBI) 
  
Post op follow up refers to a follow up encounter in clinic or by phone.  Type of  encounter is determined by time interval and medical need  
 
After completion of the pilot study, these outcomes will allow for an accurate power calculation, which will allow 
us to determine the number of patients needed for a large-scale study to determine superiority of either RALP 
or OP in the treatment of pediatric UPJ obstruction. 
 
C.2.8 Validation of the Recruitment Strategy Patients/families that agree to either participate in the randomized 
pilot study or alternatively those who agree solely to the collection of outcomes data will be brought together by 
the PEC team in order to further refine the recruitment strategy that was developed in Aim 1 (See Figure 1).  
These two groups will attend separate sessions in order to better understand what components of the 
recruitment strategy were compelling and how the strategy can be improved.   
 
C.3 Study Timeline 
 
YEAR 1 
YEAR 2 
 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Identification of Patient-Centered Outcomes 
 
 
 
 
 
 
 
 
Feasibility Study  
 
 
 
 
 
 
 
 
Data Analysis and Publication of Findings 
 
 
 
 
 
 
 
 
Writing of R01 Level Grant 
 
 
 
 
 
 
 
 
 
C.4 Potential Pitfalls 
As this is a feasibility study, there are potential hurdles that we may face in regards to executing this study.  
First, it is possible that patients/families will not chose to enroll in this study.  This is unlikely, since Aim 1 will 
seek to optimize patient participation.  If we determine with Aim 1 that a pilot study as designed would not 
result in any recruitment, we will revise our approach, including altering the methodology to an observational 
study (without randomization).  This would allow us to still gather patient-centered outcomes so that a 
subsequent effort can determine a tolerable method of randomization.  Second, it is also possible, despite 
assurances, that surgeons will not allow their patients to be randomized.  In order to prevent this occurrence, 
we will perform reviews at 3-month intervals of all pyeloplasties performed at the institution.  If randomization is 

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not occurring we will meet with all pediatric urology faculty, and the section chief (Dr. Mark Cain) will 
encourage surgeon participation.  Overall, we believe both pitfalls are very unlikely.  Moreover, determining 
points of failure such as these is the rationale for a feasibility study in the first place.  Even if a pilot randomized 
trial is not feasible, we will still have a great deal of useful patient-centered outcomes upon which to base an 
observational study and that can be used to design a more effective randomized trial in the future.   
 
 
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