Renal Stone Treatment Global Registry

Recruiting

• Conditions: Urolithiasis

• Registration Number: NCT05297331
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

Detailed Description

Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.

New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.

Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2032-12-31
• Study Completion: 2033-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patient at the age of 18 or above

Exclusion Criteria

• Patient is unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Stone status	postoperative, at 1 and/or 3 months	stone free rate

Secondary Outcome Measures

Name	Time	Method
Intraoperative parameters	intraoperative	Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics
Treatment related complication	Thirty days after the operation	The 30-day complications will be graded according to the Clavien-Dindo classification
Recurrence of stone	At 12 months	Stone recurrence rate
QOL and pain scores	preoperative, postoperative on day 0 and at follow up	Pain VAS scores and QOL assessment

Trial Locations

Locations (3)

North District Hospital; 🇭🇰 Sheung Shui, Hong Kong

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Hong Kong, Hong Kong