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Recruiting Not applicable

Medico-economic Evaluation of Management Strategies for Severe Epistaxis

NCT05281952 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-05-01
Last updated
2023-08-29

Condition(s) studied

Epistaxis

Investigational drug(s) / intervention(s)

endoscopic ligationSupra-selective embolization

endoscopic ligation: the surgical ligation of one or both sphenopalatine arteries by endoscopic way.

Supra-selective embolization: occlusion of the terminal branches of the nasal external carotid artery.

Study summary

Current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. In the absence of medico-economic studies, these recommendations could not be based on any differences in efficiency between the two techniques. The management of patients with severe non-traumatic epistaxis remains controversial and varies according to the hospital and/or university centers. In practice, the use of one or the other technique depends on the habits of each reference center.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours. * Patient over 18 years old * Affiliated patient or beneficiary of a social security scheme. * Patient accepting the principle of randomization * Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patient with epistaxis secondary to facial and/or surgical trauma. * Patient with epistaxis related to a malignant tumor cause * Patient with a history of ligation or embolization * Patient under legal protection and/or curatorship and/or guardianship. * Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health. * Patient participating in another research including an exclusion period still in progress * Pregnant or breastfeeding patient For non randomized patient * Patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, ASA score 4 * Severe hemostasis disorders that cannot benefit from correction. * History of transient and/or definitive stroke of the ischemic type * Atheromatous overload

Primary outcome measure(s)

  • incremental cost-utility ratio — Month 18
    the cost-utility ratio integrating direct medical and non-medical costs

Trial sites (1)

FacilityCityRegionStatus
University Hospital Toulouse France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05281952 on ClinicalTrials.gov ↗ ← All trials in France