Otologic Disease, Post-Op Complication
Conditions
Keywords
Ossicular surgery, Otological surgeries, Wicking
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.
Interventions
PROCEDUREWicking
Absorbable or non-absorbable wicking
PROCEDURENo wicking
No wicking after surgery
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Three experts, independent of the study, will examine the photos three months after the intervention using a standardized evaluation grid based on 10 criteria.
Intervention model description
* Experimental group: No Wicking * Control groupe: Wicking after intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tympanic and external auditory canal healing | Three months after intervention. | Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Audiometric results | Pre-operative, 3 months, 12 months | Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies. |
| Post-operative satisfaction | Immediate post-operative, day 7-10, day 30, 3 months | Visual Analogic scale (0-10 (min-max)) |
| Post-operative pain | Immediate post operative,day 7-10, day 30, 3 months | Visual Analogic scale (0-10 (min-max)) |
| Operative time | 30-120 minutes | Operative time of the otology surgery, in minutes |
| Post-operative stress | Pre-operative, day 7-10, day 30, 3 months, 12 months | Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often |
| Complications | At any time of the follow-up,up to 1 year | Questionnaire given to surgeons, allowing description of complications |
| Post-operative quality of life | Day 7-10, day 30, 3 months,12 months | Glasgow Benefit Inventory (-100 (min) to +100 (max)) |
Countries
France
Contacts
Primary ContactCharles AUSSEDAT, MD
Backup ContactWiebe de JONG, MSc
Outcome results
None listed