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临床试验/NCT05269368
NCT05269368招募中不适用

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

University Hospital, Tours12 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
12
主要终点
Tympanic and external auditory canal healing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Three experts, independent of the study, will examine the photos three months after the intervention using a standardized evaluation grid based on 10 criteria.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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,

排除标准

  • 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

结局指标

主要结局

Tympanic and external auditory canal healing

时间窗: Three months after intervention.

Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.

次要结局

  • Audiometric results(Pre-operative, 3 months, 12 months)
  • Post-operative stress(Pre-operative, day 7-10, day 30, 3 months, 12 months)
  • Post-operative pain(Immediate post operative,day 7-10, day 30, 3 months)
  • Post-operative satisfaction(Immediate post-operative, day 7-10, day 30, 3 months)
  • Operative time(30-120 minutes)
  • Complications(At any time of the follow-up,up to 1 year)
  • Post-operative quality of life(Day 7-10, day 30, 3 months,12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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