Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Not Applicable

Recruiting

• Conditions: Epistaxis
• Interventions: Procedure: Supra-selective embolization; Procedure: endoscopic ligation

• Registration Number: NCT05281952
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2023-05-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supra-selective embolization	Supra-selective embolization	-
endoscopic ligation	endoscopic ligation	-

Primary Outcome Measures

Name	Time	Method
incremental cost-utility ratio	Month 18	the cost-utility ratio integrating direct medical and non-medical costs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France