Medico-economic Evaluation of Management Strategies for Severe Epistaxis (EPICOST)

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.

Study Overview

• Status: Recruiting
• Conditions: Epistaxis
• Intervention / Treatment: Procedure: endoscopic ligation; Procedure: Supra-selective embolization

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume DE BONNECAZE, MD; Phone Number: +33 0567771641; Email: debonnecaze.g@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • University Hospital
    • Contact: Guillaume De Bonnecaze, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endoscopic ligation	Procedure: endoscopic ligation; the surgical ligation of one or both sphenopalatine arteries by endoscopic way.
Active Comparator: Supra-selective embolization	Procedure: Supra-selective embolization; occlusion of the terminal branches of the nasal external carotid artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incremental cost-utility ratio	the cost-utility ratio integrating direct medical and non-medical costs	Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
quality of life with SNOT 22		Month 18
the number of hospitalizations		Month 18
duration of hospitalizations		Month 18
the addiction with KATZ scale		Month 18
incremental cost-effectiveness ratio	the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community	Month 18
the description of the costs of care	only for non-randomized patients	Month 18
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Guillaume DE BONNECAZE, MD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Severe epistaxis; endoscopic ligation; Supra-selective embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Epistaxis
• Other Study ID Numbers: RC31/19-0550; 2020-A02824-35 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No