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

NCT06737497 | Not Yet Recruiting DMC

• 1 other identifier: Guohua Zeng
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day after sugery

• Operative time

  Surgery duration, minutes. From the insertion of the guide wire to the end of the indwelling ureteral stent.

  During surgery

Secondary Outcomes (3)

• stone-free rate

  From enrollment to the end of treatment at 1 month

• stone-free rate

  From enrollment to the end of treatment at 24 hours

• Complication rate

  1 month after sugery

Interventions

retrograde Intrarenal Surgery ( RIRS ) under local anesthesia PROCEDURE

retrograde Intrarenal Surgery ( RIRS ) under local anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with upper urinary tract stones who are willing to undergo RIRS under local anesthesia.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Guohua Zeng Ph.D and M.D

CONTACT

+8613802916676; gzgyzgh@vip.tom.com

Wen Zhong Ph.D and M.D

CONTACT

+8613631320020; gzgyzhongwen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D and M.D

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 7, 2025

Record last verified: 2024-12

Locations

CN (1)