Interest of Wicking for Ossicular Surgery and Myringoplasty

Study Overview
=================
Brief Summary
-----------------
Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Detailed Description
-----------------
Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap. Putting in place a wicking often requires to remove this wicking, feared by the patient. In addition, wicking leads to obstruction of the external acoustic meatus responsible for functional discomfort (feeling of fullness in the ear, pain, significant conductive deafness) which can last from one to several weeks depending on the type of wicking. Despite these drawbacks, the rationale for wicking has never been established, the choice of wick type is often empirical, and its necessity is sometimes controversial in the literature. Recent studies have studied the absence of wicking as an alternative to overcome its many drawbacks. No prospective, randomized, multicenter study has been performed to show the superiority of wicking in healing following middle ear surgery (myringoplasty, stapedo-vestibular ankylosis, ossiculoplasty) via the duct or the endaural route. The only study with a high level of evidence concerns only endoscopic surgery. This study has the advantage of showing that with comparable audiometric and healing results, the absence of wicking allows a reduced operating time, an earlier reduction in otorrhea and the feeling of blocked ears, and an earlier improvement of hearing. Given this work in the literature, our hypothesis is that tympanic healing is not impaired in the absence of wicking.

Official Title
-----------------
Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité

Conditions
-----------------
Post-Op Complication, Otologic Disease

Intervention / Treatment
-----------------
* Procedure: Wicking
* Procedure: No wicking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (age 18 = or + ), whose mother tongue is French or who understands French language Ossicular surgery (fitting of a partial or total ossicular prosthesis) or myringoplasty performed endoscopically, from the speculum, from the duct or from the endaural. Tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat Written consent signed by the participant Affiliation to a social security scheme, Exclusion Criteria: Pregnant or breastfeeding woman, patient under legal protection, guardianship or curatorship. Need for a retroauricular approach. Need for annulus detachment> 60% Presence of cholesteatoma or middle ear tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: No Wicking Control groupe: Wicking after intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No wicking<br>Absence of Wicking after intervention | Procedure: No wicking<br>* No wicking after surgery<br>|
| Active Comparator: Control<br>Wicking after intervention | Procedure: Wicking<br>* Absorbable or non-absorbable wicking<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanic and external auditory canal healing | Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture. | Three months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric results | Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies. | Pre-operative, 3 months, 12 months | 
| Post-operative satisfaction | Visual Analogic scale (0-10 (min-max)) | Immediate post-operative, day 7-10, day 30, 3 months | 
| Post-operative pain | Visual Analogic scale (0-10 (min-max)) | Immediate post operative,day 7-10, day 30, 3 months | 
| Post-operative quality of life | Glasgow Benefit Inventory (-100 (min) to +100 (max)) | Day 7-10, day 30, 3 months,12 months | 
| Post-operative stress | Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often | Pre-operative, day 7-10, day 30, 3 months, 12 months | 
| Operative time | Operative time of the otology surgery, in minutes | 30-120 minutes | 
| Complications | Questionnaire given to surgeons, allowing description of complications | At any time of the follow-up,up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ossicular surgery, Otological surgeries, Wicking