Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys

April 12, 2019 updated by: Abdelrahman Atef Ali, Assiut University
Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital

Description

Inclusion Criteria:

  • 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either

Exclusion Criteria:

  1. Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
  2. Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
  3. Malignancy in the target kidney
  4. Patients unlikely to undergo a nephrectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital
The percutaneous nephrostomy will be done under sonographic or fluoroscopic guidance. Establishment of intravenous access and antibiotics will be performed half an hour prior to procedure particularly in patients presenting with urinary tract infection. The procedure will be done under local anesthesia but general anesthesia may be used for uncooperative patients. percutaneous nephrostomy will be performed in the prone position, however, in case of relative contraindication to prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of increase in glomerular filtration rate after intervention
Time Frame: 3 weeks
the radioisotope measurement of glomerular filtration rate will be done before and after insertion of percutaneous nephrostomy tube
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCNHK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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