Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05297331
Collaborator
(none)
3,000
1
133
22.6

Study Details

Study Description

Brief Summary

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis in our hospital clusters.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Renal stone is a common condition in Hong Kong, 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.

    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 internal audit, treatment comparison and also patient education.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2032
    Anticipated Study Completion Date :
    Mar 31, 2033

    Outcome Measures

    Primary Outcome Measures

    1. Target Stone status [At 3 months]

      The fragmentation rate of target stone

    2. Recurrence of stone [At 12 months]

      Stone recurrent rate

    3. Treatment related complication [Thirty days after the operation]

      The 30-day complications will be graded according to the Clavien-Dindo classification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient at the age of 18 or above
    Exclusion Criteria:
    • Patient is unable to give consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Shatin Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chi Fai NG, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05297331
    Other Study ID Numbers:
    • CRE-2021.684
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2022