Analysis of the Effectiveness and Safety of RIRS Under Local Anesthesia and Its Influencing Factors

NCT ID: NCT06737497

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-07-01

Study Completion Date

2028-07-31

Brief Summary

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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。

Detailed Description

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Conditions

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Urolithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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retrograde Intrarenal Surgery ( RIRS ) under local anesthesia

retrograde Intrarenal Surgery ( RIRS ) under local anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Kidney stones or upper ureteral stones 1-4cm;
2. Age 18-70 years old;
3. American Society of Anesthesiologists(ASA) score Ⅰ, Ⅱ and Ⅲ;

Exclusion Criteria

1. Surgical operations other than RIRS are required for patients with middle and lower ureteral calculi;
2. There are anatomical abnormalities, such as ureteral stenosis, urine flow diversion, ectopic kidney, horseshoe kidney, duplicate kidney, etc.
3. Severe heart, brain and lung diseases;
4. Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Guohua Zeng

Ph.D and M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Guohua Zeng Ph.D and M.D

Role: CONTACT

+8613802916676

Wen Zhong Ph.D and M.D

Role: CONTACT

+8613631320020

Facility Contacts

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Guohua Zeng Ph.D and M.D

Role: primary

+8613802916676

Wen Zhong Ph.D and M.D

Role: backup

+8613631320020

Other Identifiers

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Guohua Zeng

Identifier Type: -

Identifier Source: org_study_id

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