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Clinical Trials/NCT05894668
NCT05894668
Recruiting
Not Applicable

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia

Chinese University of Hong Kong3 sites in 1 country1,000 target enrollmentAugust 1, 2023
ConditionsRenal Stone

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Stone
Sponsor
Chinese University of Hong Kong
Enrollment
1000
Locations
3
Primary Endpoint
Target Stone status
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.

Detailed Description

Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
March 31, 2029
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

  • Patients with urinary calculi
  • Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS)
  • Agreed to consent for the study

Exclusion Criteria

  • Patients who have ECIRS for other conditions, such as urothelial cancer etc.
  • Patients who intraoperative record was incomplete.
  • Patients only have either PCNL or ureteroscopy done (not both)

Outcomes

Primary Outcomes

Target Stone status

Time Frame: up to 1 year

The fragmentation rate of target stone

Treatment related complication

Time Frame: Thirty days after the operation

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

Study Sites (3)

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