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Status unknownNCT04090255PunctureUpdated Oct 19, 2020

Us vs Fluoroscopic Guided Renal Access

An interventional study of Renal puncture in Hydronephrosis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
6 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hydronephrosis

Browse trials for

03

Who can participate

Ages eligible
6 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • congenital anomalies of kidney
  • patient underwent transplant or urinary diversion
  • solitary kidney
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureRenal puncture

    The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

05

What researchers measure

Primary outcomes

  1. Duration of puncture

    The time taken for make a puncture

    Time frame: Within the operation

  2. duration of operation

    time taken from patient putted on table until end of operation

    Time frame: withen the operation

  3. Rate of success

    the rate success of intervention by u/s or by fluoroscopy

    Time frame: withen the operation

Secondary outcomes

  1. rate of Perioperative complication

    numbers of patients with Adverse effects occures intra operative ,bleeding ,extravasation

    Time frame: withen the operation

  2. Haemoglobin concentration change

    Compare preoperative and post operative Hg concentration

    Time frame: 24 hours post procedure

06

Study locations

1 of 1 sites recruiting
  • Mostafs Kamel Abdel Rahman
    Assiut, Sedfa 11775, Egypt
    Recruiting
07

References and documents

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. PubMed 31484611 ↗
  • Zanetti SP, Boeri L, Gallioli A, Talso M, Montanari E. Minimally invasive PCNL-MIP. Arch Esp Urol. 2017 Jan;70(1):226-234. PubMed 28221157 ↗
  • 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. PubMed 29477809 ↗
  • 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. PubMed 21740734 ↗
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Registry details

Key details

Study ID
NCT04090255
Lead sponsor
Assiut University
Responsible party
mostafa kamel abdel rahman abdel aal (Assistant lecturer, Assiut University) — Principal investigator
First posted
Sep 16, 2019
Start date
Sep 10, 2019
Primary completion
Apr 1, 2021 (estimated)
Completion
Apr 1, 2021 (estimated)
Last update
Oct 19, 2020

Study contacts

Mostafa K Abdel rahman, A lecturer
Contact
Mostafa075@gmail.com
+201061133200
Fathy G Elanany, Prof
study director · Assiut
Mohamed A Sayed, Prof
study director · Assiut
Hosney M Bahnasawy, Ass Prof
study director · Assiut

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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