Medico-economic Evaluation of Management Strategies for Severe Epistaxis

NCT ID: NCT05281952

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-31

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

Conditions

Epistaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

endoscopic ligation

Group Type: EXPERIMENTAL

endoscopic ligation

Intervention Type: PROCEDURE

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

Supra-selective embolization

Group Type: ACTIVE_COMPARATOR

Supra-selective embolization

Intervention Type: PROCEDURE

occlusion of the terminal branches of the nasal external carotid artery.

Interventions

endoscopic ligation

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

Intervention Type: PROCEDURE

Supra-selective embolization

occlusion of the terminal branches of the nasal external carotid artery.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume DE BONNECAZE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume DE BONNECAZE, MD

Role: CONTACT

debonnecaze.g@chu-toulouse.fr

0567771641 ext. +33

Facility Contacts

Guillaume DE BONNECAZE, MD

Role: primary

Other Identifiers

2020-A02824-35

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/19-0550

Identifier Type: -

Identifier Source: org_study_id