Validation of the CLAD Score Ifor Renal Colic Pain (CLAD-V)
Primary Purpose
Renal Colic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CLAD-V SCORE
Sponsored by
About this trial
This is an interventional prevention trial for Renal Colic
Eligibility Criteria
Inclusion Criteria: Adult patients admitted to the emergency room for suspected renal colic Patient not objecting to participation Exclusion Criteria: Patients unable to express their non-objection Pregnant women
Sites / Locations
- CHU de Toulouse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CLAD-V
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06026072
First Posted
August 29, 2023
Last Updated
August 29, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT06026072
Brief Title
Validation of the CLAD Score Ifor Renal Colic Pain
Acronym
CLAD-V
Official Title
Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by a lithiasis creating a transient obstruction
Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis" (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of patients to the emergency room for renal colic
The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD score and the clinician's intuition is made available to practitioners in the emergency department.
All patients presenting to the emergency room for renal colic pain are eligible. The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. The doctor must then complete the questionnaire provided.
A reminder of the patient on D7 is carried out to collect information on the need for surgery after the emergency or not.
Each center ensures inclusions and reminders on D7 and will only transmit the database
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLAD-V
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CLAD-V SCORE
Intervention Description
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.
Primary Outcome Measure Information:
Title
CLAD-V performance
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients admitted to the emergency room for suspected renal colic
Patient not objecting to participation
Exclusion Criteria:
Patients unable to express their non-objection
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic BALEN
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Validation of the CLAD Score Ifor Renal Colic Pain
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