Medico-economic Evaluation of Management Strategies for Severe Epistaxis

NCT05281952 | Recruiting

• 2 other identifiers: RC31/19-05502020-A02824-35
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Keywords

Severe epistaxis; endoscopic ligation; Supra-selective embolization

Outcome Measures

Primary Outcomes (1)

• incremental cost-utility ratio

  the cost-utility ratio integrating direct medical and non-medical costs

  Month 18

Secondary Outcomes (13)

• 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 EQ-5D-5L

  Month 18

Study Arms (2)

endoscopic ligation

EXPERIMENTAL

Procedure: endoscopic ligation

Supra-selective embolization

ACTIVE COMPARATOR

Procedure: Supra-selective embolization

Interventions

endoscopic ligation PROCEDURE

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

endoscopic ligation

Supra-selective embolization PROCEDURE

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

Supra-selective embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Guillaume DE BONNECAZE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume DE BONNECAZE, MD

CONTACT

0567771641; debonnecaze.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)