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

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ClinicalTrials.gov Identifier: NCT02713633
Recruitment Status : Terminated (Changes in staffing, original PI no longer at our institution.)
First Posted : March 21, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Rajeev Chaudhry, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Ureteropelvic Junction Obstruction Other: internal Double-J stents Other: External Stent Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Indwelling Double-J Ureteral Stent Versus Externalized Modified-Salle Stent for Pyeloplasty
Study Start Date : January 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
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.
Other: internal Double-J stents
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: 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.

internal Double-J stents
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
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: 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.




Primary Outcome Measures :
  1. Comparison of the two different Stents [ Time Frame: 4-6 weeks until the stent is removed ]
    Post-operative pain control and tolerance

  2. Comparison of the two different Stents removal [ Time Frame: 4-6 weeks until the stent is removed ]
    the ease of stent removal

  3. Comparison of the two different Stents patient satisfaction [ Time Frame: 4-6 weeks until the stent is removed ]
    Patient/parents satisfaction and cost


Secondary Outcome Measures :
  1. Compare patient/parent reported tolerance [ Time Frame: 4-6 weeks until the stent is removed ]
    assess the patient/parent reported outcomes for post-operative pain, tolerance

  2. Compare patient/parent reported outcome [ Time Frame: 4-6 weeks until the stent is removed ]
    ease of stent removal will be measured


Other Outcome Measures:
  1. Questionnaire [ Time Frame: 4-6 weeks until the stent is removed ]
    Since the validity of self-reported response is unclear at this time, data will be used to formulate future questionnaire and will be validated in set of patients. The data in the study will be presented in descriptive format for example we may find that 30% of the patients with internal stents have bladder spasms, and 40% of patients with external stents have site related pain.



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Ages Eligible for Study:   3 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Ureteropelvic Junction Obstruction

-

Exclusion Criteria: Pregnancy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713633


Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Rajeev Chaudhry
Children's Healthcare of Atlanta

Publications of Results:
Other Publications:
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Responsible Party: Rajeev Chaudhry, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02713633     History of Changes
Other Study ID Numbers: PRO14010600
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are sharing de-identified data with University of Chicago

Additional relevant MeSH terms:
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Hydronephrosis
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities