Retrograde Intrarenal Surgery In Management Of Renal StonesNCT05648877
to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones
A study testing Ureteroscope in people with Retrograde Intrarenal Surgery In Management Of Renal Stones, run by Menoufia University at 1 site in Egypt.
Trial summary
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retrograde Intrarenal Surgery In Management Of Renal Stones
- What is being tested?
- Ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with renal stones were eligible for the procedure. Patients with difficult PCNL
Who cannot join
- Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn stones
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia faculty of medicine
Shibīn al Kawm, Monufia Governorate, 32616
Mohammed A Abdelghaffar, Bachelor, 01555950089, mohammed20207501@gmail.com
About this study
Official title: Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Read the detailed description
With the advancements in endourologic technology, in the last 30 years, renal stone treatment has dramatically changed, and minimally invasive treatments options, such as extracorporeal shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL), mini-PCNL, retrograde intrarenal surgery (RIRS) or laparoscopy, have replaced open surgery.
Although, minimally invasive treatment modalities have an excellent stone fragmentation rate, the clearance of stone fragments may not be immediate and can occur for any time after the intervention.
The European Association of Urology (EAU) guidelines, recommends PCNL for renal stones greater than 2 cm, and SWL is suggested primarily for stones less than 1 cm in size. Although SWL, RIRS and PCNL are all presented as treatment options for renal stones between, which application is a matter of preference.
The treatment modality selection of renal stones usually depends on stone-related factors (location, size, and composition), clinical factors (patient's comorbidities, patient's compliance, solitary kidney, and abnormal anatomy), and technical factors (equipment available for treatment, success rates, possible complications, invasiveness, the need for anesthetics, hospitalization times, and costs).
PCNL can achieve better results but is more invasive, is associated with greater morbidity and complications, and may be reserved for selected circumstances.
Stone clearance following kidney stone treatment is not well defined. For lower pole stones, Sener and colleagues compared RIRS with SWL and reported a stone-free rate of 52.3% with patients treated using RIRS one week after treatment. However after three months, the stone-free rate improved to 100%.
Ureteroscopic lithotripsy has been the most widely applied treatment for urinary tract stones, with high success and low complication rates. The holmium laser has facilitated the disintegration of stones and increased the effectiveness of ureteroscopic lithotripsy.
Improvements in the new generation of flexible ureteroscopes have made retrograde endoscopic ureteroscopy and laser lithotripsy for renal calculi more popular. The overall success rates of retrograde intrarenal surgery have been reported as 75% to 95% for intrarenal stones > 2 cm after the first or second treatment, whereas the major and minor complication rates vary from 1.5% to 12%, which are less frequent than rates in PCNL procedures.
- Being tested
- Ureteroscope
- Keywords
- Renal pelvic stone, Semi-rigid URS, Flexible URS, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopeDevice
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
| Study group | Role | What they receive |
|---|---|---|
| 43 semirigid ureteropyeloscopy | Experimental | 43 Patients underwent semirigid ureteropyeloscopy Receives: Device: Ureteroscope |
| 34 flexible ureteropyeloscopy | Active comparator | 34 patients with flexible ureteropyeloscopy Receives: Device: Ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rates and complications
Stone free rates of both semirigid and flexible URS
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Oct 2020
- Primary completion25 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Intrarenal Surgery In Management Of Renal StonesStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali abdelghaffar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648877
- Sponsor's protocol ID
- 11/2020 urol
- Status last verified
- Jan 2023
- First submitted
- 1 Oct 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completing the thesis, I'll share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
- ClinicalTrials.gov ID
- NCT05648877
- Acronym / sponsor ID
- 11/2020 urol
- Keywords
- Renal pelvic stone, Semi-rigid URS, Flexible URS, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 25 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 13 Dec 2022 (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.
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Detailed description
With the advancements in endourologic technology, in the last 30 years, renal stone treatment has dramatically changed, and minimally invasive treatments options, such as extracorporeal shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL), mini-PCNL, retrograde intrarenal surgery (RIRS) or laparoscopy, have replaced open surgery.
Although, minimally invasive treatment modalities have an excellent stone fragmentation rate, the clearance of stone fragments may not be immediate and can occur for any time after the intervention.
The European Association of Urology (EAU) guidelines, recommends PCNL for renal stones greater than 2 cm, and SWL is suggested primarily for stones less than 1 cm in size. Although SWL, RIRS and PCNL are all presented as treatment options for renal stones between, which application is a matter of preference.
The treatment modality selection of renal stones usually depends on stone-related factors (location, size, and composition), clinical factors (patient's comorbidities, patient's compliance, solitary kidney, and abnormal anatomy), and technical factors (equipment available for treatment, success rates, possible complications, invasiveness, the need for anesthetics, hospitalization times, and costs).
PCNL can achieve better results but is more invasive, is associated with greater morbidity and complications, and may be reserved for selected circumstances.
Stone clearance following kidney stone treatment is not well defined. For lower pole stones, Sener and colleagues compared RIRS with SWL and reported a stone-free rate of 52.3% with patients treated using RIRS one week after treatment. However after three months, the stone-free rate improved to 100%.
Ureteroscopic lithotripsy has been the most widely applied treatment for urinary tract stones, with high success and low complication rates. The holmium laser has facilitated the disintegration of stones and increased the effectiveness of ureteroscopic lithotripsy.
Improvements in the new generation of flexible ureteroscopes have made retrograde endoscopic ureteroscopy and laser lithotripsy for renal calculi more popular. The overall success rates of retrograde intrarenal surgery have been reported as 75% to 95% for intrarenal stones > 2 cm after the first or second treatment, whereas the major and minor complication rates vary from 1.5% to 12%, which are less frequent than rates in PCNL procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 43 semirigid ureteropyeloscopy | Experimental | Device: Ureteroscope43 Patients underwent semirigid ureteropyeloscopy |
| 34 flexible ureteropyeloscopy | Active comparator | Device: Ureteroscope34 patients with flexible ureteropyeloscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with renal stones were eligible for the procedure. Patients with difficult PCNL
Key exclusion criteria (1 listed)
- Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn stones
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 |
|---|---|---|
| UreteroscopeRole Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience | Device | 34 flexible ureteropyeloscopy, 43 semirigid ureteropyeloscopy |
Primary outcome
stone free rates and complications
Time frame: Up to 6 months
Stone free rates of both semirigid and flexible URS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. After completing the thesis, I'll share IPD to other researchers
Related trials for Retrograde Intrarenal Surgery In Management Of Renal Stones
Active, not recruiting
PCNL Versus RIRS for Management of Stones in Solitary Kidney
Renal Stones
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Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy
Pediatric Renal Stone
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Comparison of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi
Nephrolithiasis, Renal Calculi
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscope in people with Retrograde Intrarenal Surgery In Management Of Renal Stones, run by Menoufia 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 1 inclusion and 1 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 18 Jan 2023. 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 Mohammed A Abdelghaffar, Bachelor (01555950089 ext. Menoufia, mohammed20207501@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rates and complications (time frame: Up to 6 months). 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 18 Jan 2023.