Us vs Fluoroscopic Guided Renal Access

Hydronephrosis Clinical Trial

— Puncture  

Official title:

Ultrasonography Versus Fluoroscopic Guided Renal Access

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090255
• Other study ID #: Renal puncture
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: Mostafa K Abdel rahman, A lecturer
• Phone: +201061133200
• Email: Mostafa075[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydronephrosis

Intervention

Procedure:
• Renal puncture
The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

Locations

Country	Name	City	State
Egypt	Mostafs Kamel Abdel Rahman	Assiut	Sedfa

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Chen X, Peng PX, He YH, Ding ZS, Wang JF, Tan YW, Zhou XF. [Evaluation and Comparison of SHA.LIN,S.T.O.N.E.Nephrolithometry Scoring System,and Clinical Research Office of the Endourological Society Nephrolithometry Nomogram for Predicting Stone Free Rate and Postoperative Outcomes after Percutaneous Nephrolithotomy]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Aug 30;41(4):492-500. doi: 10.3881/j.issn.1000-503X.10767. Chinese. — View Citation

Gulati M, Cheng J, Loo JT, Skalski M, Malhi H, Duddalwar V. Pictorial review: Renal ultrasound. Clin Imaging. 2018 Sep - Oct;51:133-154. doi: 10.1016/j.clinimag.2018.02.012. Epub 2018 Feb 16. Review. — View Citation

Qiu Z, Yang Y, Zhang Y, Sun YC. Modified biological training model for percutaneous renal surgery with ultrasound and fluroscopy guidance. Chin Med J (Engl). 2011 May;124(9):1286-9. — View Citation

Zanetti SP, Boeri L, Gallioli A, Talso M, Montanari E. Minimally invasive PCNL-MIP. Arch Esp Urol. 2017 Jan;70(1):226-234. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of puncture	The time taken for make a puncture	Within the operation
Primary	duration of operation	time taken from patient putted on table until end of operation	withen the operation
Primary	Rate of success	the rate success of intervention by u/s or by fluoroscopy	withen the operation
Secondary	rate of Perioperative complication	numbers of patients with Adverse effects occures intra operative ,bleeding ,extravasation	withen the operation
Secondary	Haemoglobin concentration change	Compare preoperative and post operative Hg concentration	24 hours post procedure