Perioperative Parameter and Treatment Outcomes of ECIRS in Asia

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05894668
Collaborator
(none)
1,000
3
70
333.3
4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Mar 31, 2029

Outcome Measures

Primary Outcome Measures

  1. Target Stone status [up to 1 year]

    The fragmentation rate of target stone

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

    he 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
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alice Ho Miu Ling Nethersole Hospital Hong Kong Hong Kong
2 Prince of Wales Hospital Shatin Hong Kong
3 North District Hospital Sheung Shui Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chi Fai NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05894668
Other Study ID Numbers:
  • CRE-2023.172
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
May 1, 2023
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 8, 2023