Renal StonesNCT07026721
Comparative Analysis of RIRS Scoring System and Resorlu Unsal Stone Score (RUSS) for Predicting Stone-free Rate After Retrograde Intrarenal Surgery
An observational study of Renal Stones, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
Several studies have investigated the use of scoring systems for predicting stone-free rates after RIRS. Previous research has evaluated the RIRS Scoring System, RUSS, and other similar systems in different patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- Retrograde intrarenal surgery (RIRS)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2024to 29 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with renal calculi undergoing RIRS.
Who may be able to join
- patients more than 18 years of age undergoing RIRS for renal stone
- providing informed written consent
Who cannot join
- Previous renal and ureteric surgeries
- coexisting bladder, ureteral stone
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital (TUTH), Maharajgunj, Kathmandu, Nepal
Kathmandu, Bagmati, 44600
About this study
Official title: Comparative Analysis of RIRS Scoring System and Resorlu Unsal Stone Score (RUSS) for Predicting Stone-Free Rate After Retrograde Intrarenal Surgery: A Prospective Cohort Study
Several studies have investigated the use of scoring systems for predicting stone-free rates after RIRS. Previous research has evaluated the RIRS Scoring System, RUSS, and other similar systems in different patient populations. This study was conducted to compare RIRS scoring system and Resorlu Unsal Stone Score (RUSS) for predicting stone free rate.
- Conditions
- Renal Stones
- Being tested
- Retrograde intrarenal surgery (RIRS)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgery (RIRS)Procedure or surgery
The intervention involves Retrograde Intrarenal Surgery (RIRS) performed using a flexible ureteroscope to access the renal collecting system via a retrograde (urethra → bladder → ureter → kidney) approach. Stones are fragmented using a holmium:YAG laser, with or without the use of a ureteral access sheath, depending on the case.
What distinguishes this intervention from others is the integration of preoperative scoring systems-specifically the RIRS Scoring System and the Resorlu Unsal Stone Score (RUSS)-to predict stone-free outcomes and guide case selection and surgical planning. Additionally, all procedures are performed by experienced endourologists following a standardized protocol, including consistent patient positioning, anesthesia, access technique, and post-operative imaging at defined intervals to assess outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the RIRS Scoring System and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
Measured: 12 months
Correlation between the Resorlu-Unsal Stone Score (RUSS) and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
Measured: 12 months
Secondary outcomes (2)
Stone Burden as a Predictor of Stone-Free Rate After RIRS
Correlation between stone burden (mm²) and stone-free rate after Retrograde Intrarenal Surgery (RIRS
Measured: Preoperative assessment and 1 month postoperatively for stone-free status
Stone Density as a Predictor of Stone-Free Rate After RIRS
Correlation between stone density (Hounsfield Units, HU) and stone-free rate after RIRS
Measured: Preoperative assessment and 1 month postoperatively for stone-free status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jan 2024
- Primary completion27 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajjwol Luitel, Maharajgunj Medical Campus
- Investigators
- Saro Prajapati, MBBS, MS, Study director, Department of General Surgery Maharajgunj Medical Campus Institute of Medicine, Tribhuvan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026721
- Sponsor's protocol ID
- 407(6-11)E2.080.081
- Status last verified
- Jan 2024
- First submitted
- 3 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of RIRS Scoring System and Resorlu Unsal Stone Score (RUSS) for Predicting Stone-Free Rate After Retrograde Intrarenal Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07026721
- Acronym / sponsor ID
- 407(6-11)E2.080.081
- Conditions
- Renal Stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 18 Jun 2025 (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.
Several studies have investigated the use of scoring systems for predicting stone-free rates after RIRS. Previous research has evaluated the RIRS Scoring System, RUSS, and other similar systems in different patient populations. This study was conducted to compare RIRS scoring system and Resorlu Unsal Stone Score (RUSS) for predicting stone free rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with renal calculi undergoing RIRS.
Key inclusion criteria (2 listed)
- patients more than 18 years of age undergoing RIRS for renal stone
- providing informed written consent
Key exclusion criteria (2 listed)
- Previous renal and ureteric surgeries
- coexisting bladder, ureteral stone
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 |
|---|---|---|
| Retrograde intrarenal surgery (RIRS)The intervention involves Retrograde Intrarenal Surgery (RIRS) performed using a flexible ureteroscope to access the renal collecting system via a retrograde (urethra → bladder → ureter → kidney) approach. Stones are fragmented using a holmium:YAG laser, with or without the use of a ureteral access sheath, depending on the case. What distinguishes this intervention from others is the integration of preoperative scoring systems-specifically the RIRS Scoring System and the Resorlu Unsal Stone Score (RUSS)-to predict stone-free outcomes and guide case selection and surgical planning. Additionally, all procedures are performed by experienced endourologists following a standardized protocol, including consistent patient positioning, anesthesia, access technique, and post-operative imaging at defined intervals to assess outcomes. | Procedure or surgery | – |
Primary outcome
Correlation between the RIRS Scoring System and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
Time frame: 12 months
Correlation between the Resorlu-Unsal Stone Score (RUSS) and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
Time frame: 12 months
2 secondary outcomes
Stone Burden as a Predictor of Stone-Free Rate After RIRS
Time frame: Preoperative assessment and 1 month postoperatively for stone-free status
Stone Density as a Predictor of Stone-Free Rate After RIRS
Time frame: Preoperative assessment and 1 month postoperatively for stone-free status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes
Related trials for Renal Stones
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Optimal Intrarenal Pressure During Flexible Ureteroscopy
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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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.
Saro Prajapati, MBBS, MS study director
Department of General Surgery Maharajgunj Medical Campus Institute of Medicine, Tribhuvan 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 Renal Stones, run by Maharajgunj Medical Campus at 1 site in Nepal.
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 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: finished, as of the sponsor's last update on 18 Jun 2025. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the RIRS Scoring System and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB (time frame: 12 months). The study lists 2 primary outcomes in all. 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 Jun 2025.