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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Abdelrahman Atef Ali，Assiut University

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Procedure: percutaneous nephrostomy
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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Abdelrahman Atef Ali，Assiut University

Study Sponsor ^ICMJE

Assiut University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Assiut University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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