NCT04090255

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

September 11, 2019

Last Update Submit

October 14, 2020

Conditions

Hydronephrosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • rate of Perioperative complication

    withen the operation

  • Haemoglobin concentration change

    24 hours post procedure

Study Arms (2)

Ultrasonographic guided renal access

EXPERIMENTAL

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

Fluoroscopic guided renal access

EXPERIMENTAL

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

Renal puncturePROCEDURE

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

Fluoroscopic guided renal accessUltrasonographic guided renal access

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafs Kamel Abdel Rahman

Asyut, Sedfa, 11775, Egypt

RECRUITING

Related 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.

    PMID: 31484611BACKGROUND

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

    PMID: 28221157BACKGROUND

  • 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.

    PMID: 29477809BACKGROUND

  • 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.

    PMID: 21740734BACKGROUND

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fathy G Elanany, Prof

    Assiut

    STUDY DIRECTOR

  • Mohamed A Sayed, Prof

    Assiut

    STUDY DIRECTOR

  • Hosney M Bahnasawy, Ass Prof

    Assiut

    STUDY DIRECTOR

Central Study Contacts

Mostafa K Abdel rahman, A lecturer

CONTACT

+201061133200Mostafa075@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 16, 2019

Study Start

September 10, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

EG(1)