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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

Brief Summary:
this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrolithotomy (PCNL) and pcn .

Condition or disease Intervention/treatment Phase
Renal Stone Hydronephrosis Procedure: Renal puncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ultrasonography Versus Fluoroscopic Guided Renal Access
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Stone free rate [ Time Frame: 1day after surgery ]
    Assessed by kub and CT no stone >4mm

  2. % of patients that show Decompression of the hydronephrotic kidney [ Time Frame: 1weeek after procedure ]
    By comparison of us before procedure and after procedure

  3. Duration of puncture [ Time Frame: Within the operation ]
    The time taken for make a puncture


Secondary Outcome Measures :
  1. 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

  2. Haemoglobin concentration change [ Time Frame: 24 hours post procedure ]
    Compare preoperative and post operative Hg concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090255


Contacts
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Contact: Mostafa K Abdel rahman, A lecturer +201061133200 Mostafa075@gmail.com

Locations
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Egypt
Mostafs Kamel Abdel Rahman Recruiting
Assiut, Sedfa, Egypt, 11775
Contact: mostafa k abdel rahman, resident    +201061133200    mostafa075@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Fathy G Elanany, Prof Assiut
Study Director: Mohamed A Sayed, Prof Assiut
Study Director: Hosney M Bahnasawy, Ass Prof Assiut

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: mostafa kamel abdel rahman abdel aal, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04090255     History of Changes
Other Study ID Numbers: Renal puncture
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydronephrosis
Kidney Diseases
Urologic Diseases