Ureter ObstructionNCT04980079
Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children
A study testing Primary ureterscopy URS and deferred ureteroscopy URS in people with Ureter Obstruction, run by South Valley University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Ureter Obstruction
- What is being tested?
- Primary ureterscopy URS and deferred ureteroscopy URS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mostafa
Luxor, 85951
Mostafa Mostafa, B.sc, 01069432827, mostafaalsoghier@yahoo.com
asmaa mostafa, MD, 010144437474, lalamohamed@yahoo.com
About this study
Official title: Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study
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
Read the 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.
- Conditions
- Ureter Obstruction
- Being tested
- Primary ureterscopy URS, deferred ureteroscopy URS
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ureterscopy URSProcedure or surgery
Also called URSureteroscopy
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
deferred ureteroscopy URSProcedure or surgery
insertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done .
| Study group | Role | What they receive |
|---|---|---|
| group A -undergo primary ureteroscopy URS | Active comparator | Thirty children with calicular anuria will undergo primary ureteroscopy URS Receives: Procedure: Primary ureterscopy URS |
| the group B(30 patients) will undergo deferred ureteroscopy URS | Active comparator | 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 Receives: Procedure: deferred ureteroscopy URS |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function
improvement in creatinine level mg/dl urea level mg/dl
Measured: one month .
Secondary outcomes (1)
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Apr 2021
- Primary completion15 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Mostafa, South Valley University
- Investigators
- Mostafa abdelrazek, MD, Study director, Syrian Virtual University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980079
- Sponsor's protocol ID
- calculus anuria in children
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04980079
- Acronym / sponsor ID
- calculus anuria in children
- Conditions
- Ureter Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A -undergo primary ureteroscopy URS | Active comparator | Procedure: Primary ureterscopy URSThirty children with calicular anuria will undergo primary ureteroscopy URS |
| the group B(30 patients) will undergo deferred ureteroscopy URS | Active comparator | Procedure: deferred ureteroscopy URSgroup 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 |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary ureterscopy URSAlso: URSureteroscopyUreteral 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 | Procedure or surgery | group A -undergo primary ureteroscopy URS |
| deferred ureteroscopy URSinsertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done . | Procedure or surgery | the group B(30 patients) will undergo deferred ureteroscopy URS |
Primary outcome
renal function
Time frame: one month .
improvement in creatinine level mg/dl urea level mg/dl
1 secondary outcome
the stone-free rates
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa abdelrazek, MD study director
Syrian Virtual University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary ureterscopy URS and deferred ureteroscopy URS in people with Ureter Obstruction, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa mostafa, B.sc (01069432827, mostafaalsoghier@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function (time frame: one month .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.