Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty

NCT02713633 | Terminated

• 1 other identifier: PRO14010600
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Ureteropelvic Junction Obstruction

Outcome Measures

Primary Outcomes (3)

• Comparison of the two different Stents

  Post-operative pain control and tolerance

  4-6 weeks until the stent is removed

• Comparison of the two different Stents removal

  the ease of stent removal

  4-6 weeks until the stent is removed

• Comparison of the two different Stents patient satisfaction

  Patient/parents satisfaction and cost

  4-6 weeks until the stent is removed

Secondary Outcomes (2)

• Compare patient/parent reported tolerance

  4-6 weeks until the stent is removed

• Compare patient/parent reported outcome

  4-6 weeks until the stent is removed

Other Outcomes (1)

• Questionnaire

  4-6 weeks until the stent is removed

Study Arms (2)

External Stent

OTHER

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.

Other: internal Double-J stents; Other: External Stent

internal Double-J stents

OTHER

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

Other: internal Double-J stents; Other: External Stent

Interventions

internal Double-J stents OTHER

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

External Stent; internal Double-J stents

External Stent OTHER

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.

External Stent; internal Double-J stents

Eligibility Criteria

• Age: 3 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Rajeev Chaudhry: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (3)

• 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.

  PMID: 21172705 BACKGROUND

• 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.

  PMID: 19467676 RESULT

• 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.

  PMID: 18644529 RESULT

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 21, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)