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NCT Number: NCT06737497

Analysis of the Effectiveness and Safety of 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。

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

retrograde Intrarenal Surgery ( RIRS ) under local anesthesia

Procedure

retrograde Intrarenal Surgery ( RIRS ) under local anesthesia

Primary outcomes

  1. 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.

  2. Operative time

    Time frame: During surgery

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

Secondary outcomes

  1. stone-free rate

    Time frame: From enrollment to the end of treatment at 1 month

    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.

  2. stone-free rate

    Time frame: 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.

  3. Complication rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guohua Zeng Ph.D and M.D

CONTACT

[email protected]

+8613802916676

Wen Zhong Ph.D and M.D

CONTACT

[email protected]

+8613631320020

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

Analysis of the Effectiveness and Safety of Retrograde Intrarenal Surgery (RIRS) Under Local Anesthesia and Its Influencing Factors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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