Stone UreterNCT06592469
Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter
An observational study of Stone Ureter, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stone Ureter
- What is being tested?
- Ureteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to Nov 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: .4. 2- Study subjects: 1. Inclusion criteria: * all cases with middle and lower ureteric stone candidate for endoscopy. * Stone 15mm or less. 2. Exclusion criteria: * Patients with a ureteral stent. * Patient refusing participation. * Pregnant woman. * Active urinary tract infection. * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile. 3. Sample Size Calculation: Based on previously reported frequency of primary failure of ureteocopy in case of recurrent stone that ranged between 1-37% (*reference)* a total sample size of 62 patients will be required ( 31 patients in each arm) with the following assumption; alpha error 5%, 80% power with 95% confidence interval
Who may be able to join
- • all cases with middle and lower ureteric stone candidate for endoscopy.
- Stone 15mm or less.
Who cannot join
- • Patients with a ureteral stent.
- Patient refusing participation.
- Pregnant woman.
- Active urinary tract infection.
- Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of Ureteroscopy in Fresh Versus Recurrent Cases of Stone Ureter (Post-ESWL, Endoscopy, or Open Surgery)
Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter
Read the detailed description
Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.
- Conditions
- Stone Ureter
- Being tested
- Ureteroscopy
- Keywords
- URS
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopyProcedure or surgery
Also called URS
URS is done to each group to reveal outcome of stone free rate in fresh versus recurrent cases of stone ureter
| Study group | Role | What they receive |
|---|---|---|
| Fresh cases | Outcome of URS in fresh stone ureter Receives: Procedure: Ureteroscopy | |
| Recurrent cases | Outcome of URS in recurrent cases of stone ureter post ESWL ,URS , open surgery Receives: Procedure: Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter
- Stone free rate with a mean operative time of 1 hr by MSCTKUB or Plain KUB to determine residual stones post operative
Measured: 1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative
Secondary outcomes (3)
• Rate of intraoperative findings in each group.
- Rate intraoperative findings in each group by ureteroscope
Measured: Intraoperative
• The rate of complication in each group
To determine rate of intraoperative complications as bleeding , ureteric perforation , residual stones
Measured: Intraoperative by ureteroscope and one day post operative by MSCT
• The rate of stone impaction in each group
Rate of stone impaction in each group fresh and recurrent cases
Measured: Intraoperative by ureteroscope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone UreterStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Moustafa Hussein Soliman, Assiut University
- Investigators
- Fathy Gaber Mahmoud Alanany, Prof of URO, Study director, Assiut UniversityMahmoud M. Shalaby, Prof of URO, Study director, Assiut UniversityNasreldin Abdeal Mohammed, Ass Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592469
- Sponsor's protocol ID
- Outcome of Ureteroscopy
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Ureteroscopy in Fresh Versus Recurrent Cases of Stone Ureter (Post-ESWL, Endoscopy, or Open Surgery)
- ClinicalTrials.gov ID
- NCT06592469
- Acronym / sponsor ID
- Outcome of Ureteroscopy
- Conditions
- Stone Ureter
- Keywords
- URS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter
Detailed description
Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh cases | – | Procedure: UreteroscopyOutcome of URS in fresh stone ureter |
| Recurrent cases | – | Procedure: UreteroscopyOutcome of URS in recurrent cases of stone ureter post ESWL ,URS , open surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- .4. 2- Study subjects: 1. Inclusion criteria: * all cases with middle and lower ureteric stone candidate for endoscopy. * Stone 15mm or less. 2. Exclusion criteria: * Patients with a ureteral stent. * Patient refusing participation. * Pregnant woman. * Active urinary tract infection. * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile. 3. Sample Size Calculation: Based on previously reported frequency of primary failure of ureteocopy in case of recurrent stone that ranged between 1-37% (*reference)* a total sample size of 62 patients will be required ( 31 patients in each arm) with the following assumption; alpha error 5%, 80% power with 95% confidence interval
Key inclusion criteria (2 listed)
- • all cases with middle and lower ureteric stone candidate for endoscopy.
Key exclusion criteria (5 listed)
- • Patients with a ureteral stent.
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 |
|---|---|---|
| UreteroscopyAlso: URSURS is done to each group to reveal outcome of stone free rate in fresh versus recurrent cases of stone ureter | Procedure or surgery | Fresh cases, Recurrent cases |
Primary outcome
Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter
Time frame: 1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative
• Stone free rate with a mean operative time of 1 hr by MSCTKUB or Plain KUB to determine residual stones post operative
3 secondary outcomes
• Rate of intraoperative findings in each group.
Time frame: Intraoperative
• The rate of complication in each group
Time frame: Intraoperative by ureteroscope and one day post operative by MSCT
• The rate of stone impaction in each group
Time frame: Intraoperative by ureteroscope
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Factors predicting duration and success of semirigid ureteroscopy for ureteral stones in different localizationsLink provided by the sponsor.
- Assessment of factors affecting the spontaneous passage of lower ureteric calculus on the basis of lower ureteric calculus diameter, density, and plasma C-reactive protein level. Urology AnnalLink provided by the sponsor.
- Stone composition independently predicts stone size in 18,029 spontaneously passed stonesLink provided by the sponsor.
- Outcomes of Shock Wave Lithotripsy and Ureteroscopy for Treatment of Pediatric UrolithiasisLink provided by the sponsor.
- Pushing the boundaries of ureteroscopy: current status and future perspectivesLink provided by the sponsor.
- Semirigid Ureteroscopy: Step by StepLink provided by the sponsor.
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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.
Fathy Gaber Mahmoud Alanany, Prof of URO study director
Assiut University
Mahmoud M. Shalaby, Prof of URO study director
Assiut University
Nasreldin Abdeal Mohammed, Ass Prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stone Ureter, run by Assiut 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 2 inclusion and 5 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 19 Sep 2024. 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 Amr Moustafa Hussein Soliman, Resident dr (+201140340697, amr.mustafa303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter (time frame: 1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative). 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 19 Sep 2024.