Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Last updated: August 25, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

endoscopic ligation

Supra-selective embolization

Clinical Study ID

NCT05281952
RC31/19-0550
2020-A02824-35
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 (atthe latest on the day of inclusion and before any examination required by theresearch).

Exclusion

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'scompliance due to impaired physical and/or psychological health.
  • Patient participating in another research including an exclusion period still inprogress
  • Pregnant or breastfeeding patient For non randomized patient
  • Patient with a contraindication to general anesthesia: severe and/or decompensatedcardiac/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

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: endoscopic ligation
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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

Connect with a study center

  • University Hospital

    Toulouse,
    France

    Active - Recruiting

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