CLAD-V: Validation of the CLAD Score Ifor Renal Colic Pain

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT06026072

Collaborator

(none)

1,200

Enrollment

Location

Arm

24.8

Actual Duration (Months)

48.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Colic	Other: CLAD-V SCORE	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 patientThe 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)

Primary Purpose:

Prevention

Official Title:

Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain

Actual Study Start Date :

Jul 6, 2021

Actual Primary Completion Date :

Jul 6, 2023

Actual Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: CLAD-V 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 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.

Arm

Intervention/Treatment

Other: CLAD-V

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

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.

Outcome Measures

Primary Outcome Measures

CLAD-V performance [7 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Toulouse	Toulouse	Haute-Garonne	France	31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Frederic BALEN, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT06026072

Other Study ID Numbers:

RC31/21/0124
2021-A00807-34

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colic

Renal Colic

Study Results

No Results Posted as of Sep 6, 2023