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

N/ANot Yet RecruitingNCT06737497

The First Affiliated Hospital of Guangzhou Medical University100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Urolithiasis

Interventions

retrograde Intrarenal Surgery ( RIRS ) under local anesthesiaPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 1 day after sugery

Operative time

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

Time frame: During surgery

Secondary Outcomes

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.

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

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

Time frame: 1 month after sugery