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Clinical Trials/NCT05297331
NCT05297331
Recruiting
Not Applicable

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry

Chinese University of Hong Kong3 sites in 1 country3,000 target enrollmentMarch 1, 2022
ConditionsUrolithiasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
Chinese University of Hong Kong
Enrollment
3000
Locations
3
Primary Endpoint
Target Stone status
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 31, 2033
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chi Fai NG

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Patient at the age of 18 or above

Exclusion Criteria

  • Patient is unable to give consent

Outcomes

Primary Outcomes

Target Stone status

Time Frame: postoperative, at 1 and/or 3 months

stone free rate

Secondary Outcomes

  • Intraoperative parameters(intraoperative)
  • Treatment related complication(Thirty days after the operation)
  • Recurrence of stone(At 12 months)
  • QOL and pain scores(preoperative, postoperative on day 0 and at follow up)

Study Sites (3)

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