UrolithiasisNCT06737497
Analysis of the Effectiveness and Safety of RIRS Under Local Anesthesia and Its Influencing Factors
An observational study of Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Retrograde intrarenal surgery (RIRS) is a well-established technique and is the first-line treatment option for upper urinary tract stones <2cm. Currently, most ureteroscopic procedures are performed under general or epidural anesthesia, both of which are safe and feasible. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- retrograde Intrarenal Surgery ( RIRS ) under local anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to Jul 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with upper urinary tract stones who are willing to undergo RIRS under local anesthesia.
Who may be able to join
- Kidney stones or upper ureteral stones 1-4cm;
- Age 18-70 years old;
- American Society of Anesthesiologists(ASA) score Ⅰ, Ⅱ and Ⅲ;
Who cannot join
- Surgical operations other than RIRS are required for patients with middle and lower ureteral calculi;
- There are anatomical abnormalities, such as ureteral stenosis, urine flow diversion, ectopic kidney, horseshoe kidney, duplicate kidney, etc.
- Severe heart, brain and lung diseases;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng Ph.D and M.D, +8613802916676, gzgyzgh@vip.tom.com
Wen Zhong Ph.D and M.D, +8613631320020, gzgyzhongwen@163.com
About this study
Official title: Analysis of the Effectiveness and Safety of Retrograde Intrarenal Surgery (RIRS) Under Local Anesthesia and Its Influencing Factors
Retrograde intrarenal surgery (RIRS) is a well-established technique and is the first-line treatment option for upper urinary tract stones <2cm. Currently, most ureteroscopic procedures are performed under general or epidural anesthesia, both of which are safe and feasible. In recent years, more and more studies have shown that retrograde intrarenal surgery (RIRS) under local anesthesia is safe and feasible. However, we can see that the current studies on RIRS under local anesthesia are mostly case reports, and there is a lack of systematic studies on the safety and effectiveness of RIRS under local anesthesia and its influencing factors. Therefore, the researchers hope to conduct a single-center prospective observational study to explore the safety, effectiveness and influencing factors of RIRS under local anesthesia, so as to optimize the surgical process of RIRS under local anesthesia, improve the surgical success rate and ensure surgical safety。
- Conditions
- Urolithiasis
- Being tested
- retrograde Intrarenal Surgery ( RIRS ) under local anesthesia
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde Intrarenal Surgery ( RIRS ) under local anesthesiaProcedure or surgery
retrograde Intrarenal Surgery ( RIRS ) under local anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Visual Analogue Scale(VAS)，The basic method is to use a moving ruler about 10cm long, with 10 scales on one side and "0" and "10" points on both ends, where 0 represents no pain and 10 represents the most unbearable pain.
Measured: 1 day after sugery
Operative time
Surgery duration, minutes. From the insertion of the guide wire to the end of the indwelling ureteral stent.
Measured: During surgery
Secondary outcomes (3)
stone-free rate
A low-dose and ultrathin 2-mm spiral CT was performed at 1 day postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.
Measured: From enrollment to the end of treatment at 1 month
stone-free rate
A low-dose and ultrathin 2-mm spiral CT was performed at 1 day postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.
Measured: From enrollment to the end of treatment at 24 hours
Complication rate
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system
Measured: 1 month after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737497
- Sponsor's protocol ID
- Guohua Zeng
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness and Safety of Retrograde Intrarenal Surgery (RIRS) Under Local Anesthesia and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT06737497
- Acronym / sponsor ID
- Guohua Zeng
- Conditions
- Urolithiasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Dec 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.
Retrograde intrarenal surgery (RIRS) is a well-established technique and is the first-line treatment option for upper urinary tract stones <2cm. Currently, most ureteroscopic procedures are performed under general or epidural anesthesia, both of which are safe and feasible. In recent years, more and more studies have shown that retrograde intrarenal surgery (RIRS) under local anesthesia is safe and feasible. However, we can see that the current studies on RIRS under local anesthesia are mostly case reports, and there is a lack of systematic studies on the safety and effectiveness of RIRS under local anesthesia and its influencing factors. Therefore, the researchers hope to conduct a single-center prospective observational study to explore the safety, effectiveness and influencing factors of RIRS under local anesthesia, so as to optimize the surgical process of RIRS under local anesthesia, improve the surgical success rate and ensure surgical safety。
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper urinary tract stones who are willing to undergo RIRS under local anesthesia.
Key inclusion criteria (3 listed)
- Kidney stones or upper ureteral stones 1-4cm;
- Age 18-70 years old;
- American Society of Anesthesiologists(ASA) score Ⅰ, Ⅱ and Ⅲ;
Key exclusion criteria (4 listed)
- Surgical operations other than RIRS are required for patients with middle and lower ureteral calculi;
- There are anatomical abnormalities, such as ureteral stenosis, urine flow diversion, ectopic kidney, horseshoe kidney, duplicate kidney, etc.
- Severe heart, brain and lung diseases;
- Pregnancy.
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 ) under local anesthesiaretrograde Intrarenal Surgery ( RIRS ) under local anesthesia | Procedure or surgery | – |
Primary outcome
pain score
Time frame: 1 day after sugery
Visual Analogue Scale(VAS)，The basic method is to use a moving ruler about 10cm long, with 10 scales on one side and "0" and "10" points on both ends, where 0 represents no pain and 10 represents the most unbearable pain.
Operative time
Time frame: During surgery
Surgery duration, minutes. From the insertion of the guide wire to the end of the indwelling ureteral stent.
3 secondary outcomes
stone-free rate
Time frame: From enrollment to the end of treatment at 1 month
stone-free rate
Time frame: From enrollment to the end of treatment at 24 hours
Complication rate
Time frame: 1 month after sugery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
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 Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 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: opening soon, as of the sponsor's last update on 7 Mar 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng Ph.D and M.D (+8613802916676, gzgyzgh@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 1 day after sugery). 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 7 Mar 2025.