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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06026072
Other study ID # RC31/21/0124
Secondary ID 2021-A00807-34
Status Completed
Phase N/A
First received
Last updated
Start date July 6, 2021
Est. completion date July 30, 2023

Study information

Verified date August 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date July 30, 2023
Est. primary completion date July 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CLAD-V SCORE
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.

Locations

Country Name City State
France CHU de Toulouse Toulouse Haute-Garonne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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