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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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