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

NCT02713633 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-04-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Rajeev Chaudhry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713633 on ClinicalTrials.gov