NCT03695991

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

October 3, 2018

Last Update Submit

April 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of increase in glomerular filtration rate after intervention

    the radioisotope measurement of glomerular filtration rate will be done before and after insertion of percutaneous nephrostomy tube

    3 weeks

Study Arms (1)

Study group

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

Procedure: percutaneous nephrostomy

Interventions

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 group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \) 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hydronephrosis

Interventions

Nephrostomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisOstomySurgical Procedures, OperativeNephrotomyUrologic Surgical ProceduresUrogenital Surgical ProceduresUrinary Diversion

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

May 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04