Clinical trial NCT02713633: Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty
Official title: Prospective Randomized Trial of Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ureteropelvic Junction Obstruction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2016-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study, Randomized Trial of Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty will consist of four steps: 1.) Enrolling subjects in the study and signing the consent form 2.) Randomly divide subjects into 2 groups, group 1 will have internal stent and group 2 will have external stent 3.) At the time of stent removal in the clinic or in the OR subjects parents/ subjects will fill a questionnaire about pain after the procedure, stent care and stent tolerance and 4) Data from the questionnaires and procedure cost will be collected and all the data will be analyzed

Detailed description: The pyeloplasty is a surgical procedure to treat kidney obstruction due to congenital or acquired causes. Congenital like congenital stenosis in the Uretero-pelvic junction (UPJ) or due to crossing blood vessels. Acquired causes like UPJ obstruction post stone disease or renal trauma. For the congenital or the acquired causes the principle of the surgery is to remove the UPJ stenosis (the diseased segment of the ureter) and reconnect the ureter to the renal pelvis again. This procedure is known as dismembered pyeloplasty. It was described in 1940 by Anderson and since then still the gold standard procedure regardless of the approach (open, laparoscopic or robotic). One of the principles of the procedure is to 'Splint' the anastomosis, i.e put something across the anastomosis during the healing process that includes internal and external stents. Also there are surgeons even don't believe in keeping anything across the anastomosis, but they leave a nephrostomy tube only that will not cross the anastomosis. In our division at CHP, we believe that we should keep a stent across the anastomosis to help in the healing process and decrease that chance of intra-abdominal urine leak and to increase the chance of success (90-99%). So for the internal stent, we use to approaches to insert it: 1- Retrograde by cystoscopy and this will take 10 minutes before starting the surgical procedure itself and we put the stent under fluoroscopy guidance and this is the commonest way we use now to put the internal stents. 2- ante grade, and this is basically inserting the stent during the surgical procedure itself from the kidney down to the ureter and this is done without fluoroscopy. For the external stent we use one method, we choose were we will leave the stent and then we create a small hole in the kidney and then pull the stent through the hole and then create small hole in the abdominal fascia and then the skin, all this done under direct vision and control. So now the sent is outside the patient and connected directly to the kidney and the renal pelvis, then the distal part of the stent will be inserted across the anastomosis and before closing the renal pelvis (also under vision) toward the ureter. The external stent will be connected at the end of the procedure to a urine bag. The type of the procedure will not affect out choice of the type of the stent, as both stents can be inserted using the open, laparoscopic or robotic approach. No difference in the choice for antibiotics or pain medication, again because we will perform the same exact surgery (open, lap or robotic pyeloplasty) and so the same incisions. All out patients receive pre and post-operative antibiotics and this will not be different in both groups. For the alternative method, simply is choosing the first patient for example for internal stent, the second patient we will use external stent, the third patient we will use internal stent, then external , then internal..etc. We will not choose the patient according to age or sex. Of course after we tell the parents and the patient about the study and they choose not to enroll, we will use the internal stent as we usually do. Basically all the pyeloplasty surgeries (open, Lap or robotic) are done as inpatient. All the patients will spend the night in the hospital with Foley catheter and next day and after full evaluation most of the patients will be sent home. All the pyeloplasty surgeries are done under general anesthesia.

This is prospective study to compare the post-operative pain, stent tolerance, stent care and total cost of a common procedure in pediatric urology which is pyeloplasty. The patients will be randomized into 2 groups. All female subjects will undergo a standard urine pregnancy test to rule out pregnancy. The first group will be patients who will have internal Double-J stents and the second group will be patients who will have external Pippi-Salle nephron-ureteric stent. The parents and the patient will be informed at the day of the surgery about the type of stent he/she will have at the end of the surgery. In the post-operative period, the patient will stay overnight (as for all the non-study patients) and next morning his/her Foley catheter will be removed. The patient and his/her family will receive instructions about the care for external stent (if he/she has one) and receive the regular prescriptions for pain medicine and Oxybutynin (if the patient has internal stent). All patients will be given contact information to call in case they have concerns or questions about the study, the procedure itself or the stents.

Patients will be randomized to the two different post-operative stent treatments using block randomization with permuted blocks. Block randomization will help ensure that by the end of the study we have a reasonably similar number of patients in each treatment group. Given that the investigators are necessarily unmasked in this study since they are placing the stents, randomly permuted blocks will ensure that the investigators cannot identify the pattern and predict the stent the next patient will receive.

The website www.randomization.com has been used to generate a randomization schedule using block sizes of 9 and 6. This suggests an estimated 45 patients will be recruited at a single site so that across 2 institutions about 90 patients will be recruited with approximately 30 patients total per treatment group by the end of the study.

The Principal Investigator is Dr. Michael C. Ost, M.D, chief of the division of Pediatric urology with the research pediatric urology fellow Dr. Pankaj Dangel, M.D and the clinical pediatric urology fellow Dr. Moira Dwyer, M.D. All the patients' names, details of the procedures and the parents/patients questionnaires will be kept as part of medical records that is protected by the HIPPA regulations for confidentiality.

Eligibility criteria: Inclusion Criteria: Ureteropelvic Junction Obstruction

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Exclusion Criteria: Pregnancy

Primary outcomes:
measure: Comparison of the two different Stents
timeFrame: 4-6 weeks until the stent is removed
measure: Comparison of the two different Stents removal
timeFrame: 4-6 weeks until the stent is removed
measure: Comparison of the two different Stents patient satisfaction
timeFrame: 4-6 weeks until the stent is removed
Secondary outcomes:
measure: Compare patient/parent reported tolerance
timeFrame: 4-6 weeks until the stent is removed
measure: Compare patient/parent reported outcome
timeFrame: 4-6 weeks until the stent is removed
Other outcomes:
measure: Questionnaire
timeFrame: 4-6 weeks until the stent is removed
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
References:
citation: Yiee JH, Baskin LS. Use of internal stent, external transanastomotic stent or no stent during pediatric pyeloplasty: a decision tree cost-effectiveness analysis. J Urol. 2011 Feb;185(2):673-80. doi: 10.1016/j.juro.2010.09.118. Epub 2010 Dec 18.
citation: Castagnetti M, Rigamonti W. Re: Outcome analysis and cost comparison between externalized pyeloureteral and standard stents in 470 consecutive open pyeloplasties. L. H. P. Braga, A. J. Lorenzo, W. A. Farhat, D. J. Bagli, A. E. Khoury and J. L. Pippi Salle. J Urol 2008; 180: 1693-1699. J Urol. 2009 Jul;182(1):399-400. doi: 10.1016/j.juro.2009.02.152. Epub 2009 May 20. No abstract available.
citation: Elmalik K, Chowdhury MM, Capps SN. Ureteric stents in pyeloplasty: a help or a hindrance? J Pediatr Urol. 2008 Aug;4(4):275-9. doi: 10.1016/j.jpurol.2008.01.205. Epub 2008 Mar 7.