Back to resultsPrimary Versus Deferred Ureteroscopy for Calculus Anuria in Children
Primary Purpose
Ureter Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Primary ureterscopy URS
deferred ureteroscopy URS
Sponsored by
About this trial
This is an interventional treatment trial for Ureter Obstruction
Eligibility Criteria
Inclusion Criteria:
- Children ˂12 years with calculus anuria.
- Clinically stable (serum creatinine < 3.5 mg/dl, blood urea < 100 mg/dl,serum potassium level < 7 milliequivalent /L and /or ph of blood > 7.1)
- All the patients free of sepsis.
Exclusion Criteria:
- Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
- Children with underlying urological structural abnormalities
Sites / Locations
- MostafaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group A -undergo primary ureteroscopy URS
the group B(30 patients) will undergo deferred ureteroscopy URS
Arm Description
Thirty children with calicular anuria will undergo primary ureteroscopy URS
group B (30) patients will be admitted to do urinary drainage through the insertion of a double-J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done
Outcomes
Primary Outcome Measures
renal function
improvement in creatinine level mg/dl urea level mg/dl
Secondary Outcome Measures
the stone-free rates
The clinical outcomes of the procedures including the perioperative complications :
of perforation
of infection
of residual stones
of the stone-free rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04980079
Brief Title
Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children
Official Title
Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the role of both primary and deferred URS in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study
Detailed Description
Thirty group B (30) patients will be admitted to do urinary drainage through the insertion of a JJ stent or percutaneous nephrostomy (PCN) at first , then a deferred URS will be done children will undergo primary URS( group A ) and in. Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy. Postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A -undergo primary ureteroscopy URS
Arm Type
Active Comparator
Arm Description
Thirty children with calicular anuria will undergo primary ureteroscopy URS
Arm Title
the group B(30 patients) will undergo deferred ureteroscopy URS
Arm Type
Active Comparator
Arm Description
group B (30) patients will be admitted to do urinary drainage through the insertion of a double-J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done
Intervention Type
Procedure
Intervention Name(s)
Primary ureterscopy URS
Other Intervention Name(s)
URSureteroscopy
Intervention Description
Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy
Intervention Type
Procedure
Intervention Name(s)
deferred ureteroscopy URS
Intervention Description
insertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done .
Primary Outcome Measure Information:
Title
renal function
Description
improvement in creatinine level mg/dl urea level mg/dl
Time Frame
one month .
Secondary Outcome Measure Information:
Title
the stone-free rates
Description
The clinical outcomes of the procedures including the perioperative complications :
of perforation
of infection
of residual stones
of the stone-free rates
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children ˂12 years with calculus anuria.
Clinically stable (serum creatinine < 3.5 mg/dl, blood urea < 100 mg/dl,serum potassium level < 7 milliequivalent /L and /or ph of blood > 7.1)
All the patients free of sepsis.
Exclusion Criteria:
Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
Children with underlying urological structural abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa mostafa, B.sc
Phone
01069432827
Email
mostafaalsoghier@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa abdelrazek, MD
Organizational Affiliation
SVU
Official's Role
Study Director
Facility Information:
Facility Name
Mostafa
City
Luxor
ZIP/Postal Code
85951
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa Mostafa, B.sc
Phone
01069432827
Email
mostafaalsoghier@yahoo.com
First Name & Middle Initial & Last Name & Degree
asmaa mostafa, MD
Phone
010144437474
Email
lalamohamed@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children
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