Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Epistaxis Clinical Trial

— EPICOST  

Official title:

Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281952
• Other study ID #: RC31/19-0550
• Secondary ID: 2020-A02824-35
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: Guillaume DE BONNECAZE, MD
• Phone: 0567771641
• Email: debonnecaze.g[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective embolization. This medico-economic superiority could go through: - reduction in the number of recurrences - reduction in the length of hospital stays. - reduction in the cost of postoperative care. - reduction of iatrogenic complications - improvement of functional suites upon return home. - Tertiary prevention of dependency, particularly among the elderly

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incremental cost-utility ratio	the cost-utility ratio integrating direct medical and non-medical costs	Month 18
Secondary	number of recurrences		Month 18
Secondary	time to first recurrence		Month 18
Secondary	the number of complications		Month 18
Secondary	nature of complications		Month 18
Secondary	quality of life with EQ-5D-5L		Month 18
Secondary	quality of life with SNOT 22		Month 18
Secondary	the number of hospitalizations		Month 18
Secondary	duration of hospitalizations		Month 18
Secondary	the addiction with KATZ scale		Month 18
Secondary	incremental cost-effectiveness ratio	the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community	Month 18
Secondary	the description of the costs of care	only for non-randomized patients	Month 18
Secondary	financial benefit (1 year)	the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective	Month 12
Secondary	financial benefit (5 year)	the 5-year financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective	Year 5