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Us vs Fluoroscopic Guided Renal Access (Puncture)

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ClinicalTrials.gov Identifier: NCT04090255
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
mostafa kamel abdel rahman abdel aal, Assiut University

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE September 10, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Stone free rate [ Time Frame: 1day after surgery ]
    Assessed by kub and CT no stone >4mm
  • % of patients that show Decompression of the hydronephrotic kidney [ Time Frame: 1weeek after procedure ]
    By comparison of us before procedure and after procedure
  • Duration of puncture [ Time Frame: Within the operation ]
    The time taken for make a puncture
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • rate of Perioperative complication [ Time Frame: 30 days after surgery ]
    numbers of patients with Adverse effects occures intra operative or after like fever ,bleeding ,extravasation and septic shock
  • Haemoglobin concentration change [ Time Frame: 24 hours post procedure ]
    Compare preoperative and post operative Hg concentration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Us vs Fluoroscopic Guided Renal Access
Official Title  ICMJE Ultrasonography Versus Fluoroscopic Guided Renal Access
Brief Summary this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrolithotomy (PCNL) and pcn .
Detailed Description investigators will enroll 100 patients who are candidates for PCNL or 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Stone
  • Hydronephrosis
Intervention  ICMJE Procedure: Renal puncture
The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcnl or only pcn
Study Arms  ICMJE
  • Experimental: Ultrasonographic guided renal access
    The use of ultrasound to make a puncture in kidney for pcnl for stone removal or for pcn for drainage
    Intervention: Procedure: Renal puncture
  • Experimental: Fluoroscopic guided renal access
    The use of fluoroscopy to make a puncture in kidney for pcnl for stone removal or for pcn for drainage
    Intervention: Procedure: Renal puncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • infected hydronephrotic thin cortex
  • american society of anesthesiology score 1,2
  • no congenital anomalies
  • kidney stone >2cm

Exclusion Criteria:

  • congenital anomalies of kidney
  • patient underwent transplant or urinary diversion
  • solitary kidney
  • asymptomatic hydronephrotic lost cortex kidney
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mostafa K Abdel rahman, A lecturer +201061133200 Mostafa075@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090255
Other Study ID Numbers  ICMJE Renal puncture
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party mostafa kamel abdel rahman abdel aal, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fathy G Elanany, Prof Assiut
Study Director: Mohamed A Sayed, Prof Assiut
Study Director: Hosney M Bahnasawy, Ass Prof Assiut
PRS Account Assiut University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP