NCT06026072

Brief Summary

Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

August 29, 2023

Last Update Submit

August 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CLAD-V performance

    Validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain

    7 days

Study Arms (1)

CLAD-V

OTHER

All patient with renal colic will be eligible. The CLAD-V score will fills by the doctor and seven days after the patient will call back to know if he had a surgical intervention or no.

Other: CLAD-V SCORE

Interventions

the CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no.

CLAD-V

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients admitted to the emergency room for suspected renal colic
  • Patient not objecting to participation

You may not qualify if:

  • Patients unable to express their non-objection
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, Haute-Garonne, 31059, France

Location

MeSH Terms

Conditions

Renal Colic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic BALEN

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

July 6, 2021

Primary Completion

July 6, 2023

Study Completion

July 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations