NCT05707988

Brief Summary

Urolithiasis is a frequent pathology, for which flexible ureteroscopy with endocorporeal laser lithotripsy has become the most frequently used surgical treatment. This procedure is limited to 90 minutes and will depend mainly on the total lithiasis volume. Knowing the duration of lithotripsy before the operation would allow to foresee situations of iterative procedures and to improve the patient's path (ambulatory or conventional surgery, work stoppage, optimization of operating times and operating room occupation times). "Kidney Stone Calculator" is a free tool capable of providing a calculi volumetry and predicting the duration of endocorporeal laser lithotripsy. The main objective of this study would be to evaluate the performance of the Kidney Stone Calculator in estimating the duration of laser lithotripsy during flexible ureteroscopy for renal calculi, by analyzing the agreement between the estimated and actual lithotripsy durations, evaluated by an intraclass correlation coefficient and its 95% confidence interval Eligible patients will be those scheduled for flexible ureteroscopy for renal calculi described on a non-injected abdominopelvic scan. A total of 240 patients over a 15-month inclusion period is planned, with a follow-up time of 3 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 23, 2023

Last Update Submit

January 23, 2023

Conditions

Urolithiasis

Keywords

LaserUrolithiasisEndoscopyUreteroscopy

Outcome Measures

Primary Outcomes (1)

  • Concordance

    Concordance between estimated and actual laser lithotripsy times during flexible ureteroscopy for kidney stones, assessed by an intraclass correlation coefficient and its 95% confidence interval

    3 months

Secondary Outcomes (2)

  • Correlation between Des and Def according to demographic, anatomical, number and types of calculi and their position, material

    3 months

  • Comparison of the surgeon's planned laser parameters and those used during the procedure for lithiasis fragmentation

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be defined as the population respecting the following criterias : Patient will be enrolled at the preoperative urologic consultation. Inclusion Criteria : * Age ≥ 18 years * One or more kidney stones documented on a preoperative non-injected abdominopelvic CT scan * scheduled for flexible ureteroscopy with endocorporeal laser lithotripsy * using a reference laser (Holmium:YAG or Thulium Fiber) * no opposition to the reuse of care data for research Exclusion Criteria : * Ureteral calculi * Encrusted JJ stent * Percutaneous surgical stone management * Planned monobloc extraction of the stone * Suspicion of struvite type stone (phosphasto-amoniacal-magnesium)

You may qualify if:

  • Age ≥ 18 years
  • One or more kidney stones documented on a preoperative non-injected abdominopelvic CT scan
  • scheduled for flexible ureteroscopy with endocorporeal laser lithotripsy
  • using a reference laser (Holmium:YAG or Thulium Fiber)
  • no opposition to the reuse of care data for research

You may not qualify if:

  • Ureteral calculi
  • Encrusted JJ stent
  • Percutaneous surgical stone management
  • Planned monobloc extraction of the stone
  • Suspicion of struvite type stone (phosphasto-amoniacal-magnesium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department, Tenon Hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Frédéric PANTHIER, MD, MSc

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric PANTHIER, MD, MSc

CONTACT

0156016460frederic.panthier@aphp.fr

Oliver TRAXER, MD PhD

CONTACT

0156016460Olivier.traxer@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

February 1, 2023

Primary Completion

November 1, 2024

Study Completion

February 1, 2025

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

FR(1)