Us vs Fluoroscopic Guided Renal Access (Puncture)

Ultrasonography Versus Fluoroscopic Guided Renal Access

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

Study Overview

• Status: Unknown
• Conditions: Hydronephrosis
• Intervention / Treatment: Procedure: Renal puncture

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sedfa
    • Assiut, Sedfa, Egypt, 11775
      • Recruiting
      • Mostafs Kamel Abdel Rahman
      • Contact: mostafa k abdel rahman, resident; Phone Number: +201061133200; Email: mostafa075@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasonographic guided renal access; The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine	Procedure: Renal puncture; The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn
EXPERIMENTAL: Fluoroscopic guided renal access; The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine	Procedure: Renal puncture; The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Fathy G Elanany, Prof, Assiut; Study Director: Mohamed A Sayed, Prof, Assiut; Study Director: Hosney M Bahnasawy, Ass Prof, Assiut

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hydronephrosis
• Other Study ID Numbers: Renal puncture

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No