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

Not yet recruiting

• Conditions: Urolithiasis

• Registration Number: NCT06737497
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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。

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-17
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Start: 2026-07-01
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain score	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	During surgery	Surgery duration, minutes. From the insertion of the guide wire to the end of the indwelling ureteral stent.

Secondary Outcome Measures

Name	Time	Method
stone-free rate	From enrollment to the end of treatment at 24 hours	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.
Complication rate	1 month after sugery	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

Trial Locations

Locations (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China