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Us vs Fluoroscopic Guided Renal Access (Puncture)

Primary Purpose

Hydronephrosis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Renal puncture

About this trial

This is an interventional treatment trial for Hydronephrosis

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mostafs Kamel Abdel RahmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ultrasonographic guided renal access

Fluoroscopic guided renal access

Arm Description

The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Outcomes

Primary Outcome Measures

Duration of puncture

The time taken for make a puncture

duration of operation

time taken from patient putted on table until end of operation

Rate of success

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

Secondary Outcome Measures

rate of Perioperative complication

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

Haemoglobin concentration change

Compare preoperative and post operative Hg concentration

Full Information

NCT ID

NCT04090255

First Posted

September 11, 2019

Last Updated

October 14, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04090255

Brief Title

Us vs Fluoroscopic Guided Renal Access

Acronym

Puncture

Official Title

Ultrasonography Versus Fluoroscopic Guided Renal Access

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 10, 2019 (Actual)

Primary Completion Date

April 1, 2021 (Anticipated)

Study Completion Date

April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydronephrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasonographic guided renal access

Arm Type

Experimental

Arm Description

The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Arm Title

Fluoroscopic guided renal access

Arm Type

Experimental

Arm Description

The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Intervention Type

Procedure

Intervention Name(s)

Renal puncture

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of puncture

Description

The time taken for make a puncture

Time Frame

Within the operation

Title

duration of operation

Description

time taken from patient putted on table until end of operation

Time Frame

withen the operation

Title

Rate of success

Description

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

Time Frame

withen the operation

Secondary Outcome Measure Information:

Title

rate of Perioperative complication

Description

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

Time Frame

withen the operation

Title

Haemoglobin concentration change

Description

Compare preoperative and post operative Hg concentration

Time Frame

24 hours post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa K Abdel rahman, A lecturer

Phone

+201061133200

Mostafa075@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fathy G Elanany, Prof

Organizational Affiliation

Assiut

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed A Sayed, Prof

Organizational Affiliation

Assiut

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hosney M Bahnasawy, Ass Prof

Organizational Affiliation

Assiut

Official's Role

Study Director

Facility Information:

Facility Name

Mostafs Kamel Abdel Rahman

City

Assiut

State/Province

Sedfa

ZIP/Postal Code

11775

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mostafa k abdel rahman, resident

Phone

+201061133200

mostafa075@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

31484611

Citation

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.

Results Reference

background

PubMed Identifier

28221157

Citation

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

Results Reference

background

PubMed Identifier

29477809

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.

Results Reference

background

PubMed Identifier

21740734

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.

Results Reference

background

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Us vs Fluoroscopic Guided Renal Access

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