Us vs Fluoroscopic Guided Renal Access

Not Applicable

• Conditions: Hydronephrosis
• Interventions: Procedure: Renal puncture

• Registration Number: NCT04090255
• Lead Sponsor: Assiut University

Brief Summary

this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn .

Detailed Description

investigators will enroll 100 patients who are candidates for PCN in the study. By simple random sampling technique, patients will be assigned to two patient groups (group 1, US-guided approach , group 2, fluoroscopy-guided approach.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Study Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• infected hydronephrotic kidney onen's grade 2-3
• obstructed good cortex with backpressure changes onen's grade 2-3 .
• Evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4

Exclusion Criteria

• congenital anomalies of kidney
• patient underwent transplant or urinary diversion
• solitary kidney

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonographic guided renal access	Renal puncture	The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine
Fluoroscopic guided renal access	Renal puncture	The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Primary Outcome Measures

Name	Time	Method
duration of operation	withen the operation	time taken from patient putted on table until end of operation
Duration of puncture	Within the operation	The time taken for make a puncture
Rate of success	withen the operation	the rate success of intervention by u/s or by fluoroscopy

Secondary Outcome Measures

Name	Time	Method
Haemoglobin concentration change	24 hours post procedure	Compare preoperative and post operative Hg concentration
rate of Perioperative complication	withen the operation	numbers of patients with Adverse effects occures intra operative ,bleeding ,extravasation

Trial Locations

Locations (1)

Mostafs Kamel Abdel Rahman; 🇪🇬 Assiut, Sedfa, Egypt