Interest of Wicking for Ossicular Surgery and Myringoplasty (MECH-ORL)
Primary Purpose
Post-Op Complication, Otologic Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Wicking
No wicking
Sponsored by
About this trial
This is an interventional supportive care trial for Post-Op Complication focused on measuring Ossicular surgery, Otological surgeries, Wicking
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
Sites / Locations
- Hospital BloisRecruiting
- University Hospital BREST
- Hospital Le MansRecruiting
- University Hospital NANTESRecruiting
- Hospital La Pitié Salpêtrière-APHPRecruiting
- University Hospital TOURSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No wicking
Control
Arm Description
Absence of Wicking after intervention
Wicking after intervention
Outcomes
Primary Outcome Measures
Tympanic and external auditory canal healing
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
Secondary Outcome Measures
Audiometric results
Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Post-operative satisfaction
Visual Analogic scale (0-10 (min-max))
Post-operative pain
Visual Analogic scale (0-10 (min-max))
Post-operative quality of life
Glasgow Benefit Inventory (-100 (min) to +100 (max))
Post-operative stress
Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Operative time
Operative time of the otology surgery, in minutes
Complications
Questionnaire given to surgeons, allowing description of complications
Full Information
NCT ID
NCT05269368
First Posted
January 21, 2022
Last Updated
July 5, 2022
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT05269368
Brief Title
Interest of Wicking for Ossicular Surgery and Myringoplasty
Acronym
MECH-ORL
Official Title
Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
May 16, 2025 (Anticipated)
Study Completion Date
May 16, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication, Otologic Disease
Keywords
Ossicular surgery, Otological surgeries, Wicking
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: No Wicking
Control groupe: Wicking after intervention
Masking
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.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No wicking
Arm Type
Experimental
Arm Description
Absence of Wicking after intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Wicking after intervention
Intervention Type
Procedure
Intervention Name(s)
Wicking
Intervention Description
Absorbable or non-absorbable wicking
Intervention Type
Procedure
Intervention Name(s)
No wicking
Intervention Description
No wicking after surgery
Primary Outcome Measure Information:
Title
Tympanic and external auditory canal healing
Description
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
Time Frame
Three months after intervention.
Secondary Outcome Measure Information:
Title
Audiometric results
Description
Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Time Frame
Pre-operative, 3 months, 12 months
Title
Post-operative satisfaction
Description
Visual Analogic scale (0-10 (min-max))
Time Frame
Immediate post-operative, day 7-10, day 30, 3 months
Title
Post-operative pain
Description
Visual Analogic scale (0-10 (min-max))
Time Frame
Immediate post operative,day 7-10, day 30, 3 months
Title
Post-operative quality of life
Description
Glasgow Benefit Inventory (-100 (min) to +100 (max))
Time Frame
Day 7-10, day 30, 3 months,12 months
Title
Post-operative stress
Description
Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Time Frame
Pre-operative, day 7-10, day 30, 3 months, 12 months
Title
Operative time
Description
Operative time of the otology surgery, in minutes
Time Frame
30-120 minutes
Title
Complications
Description
Questionnaire given to surgeons, allowing description of complications
Time Frame
At any time of the follow-up,up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles AUSSEDAT, MD
Phone
+33247474747
Ext
74518
Email
c.aussedat@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Wiebe de JONG, MSc
Phone
+33247474680
Email
w.dejong@chu-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles AUSSEDAT, MD
Organizational Affiliation
University Hospital of TOURS
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Blois
City
Blois
ZIP/Postal Code
41000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles-Edouard ROUF, MD-PhD
Phone
+33254556525
Email
charles.rouf@outlook.com
Facility Name
University Hospital BREST
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hospital Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine BOBIN, MD-PhD
Phone
+33243434325
Email
catherinebobin@gmail.com
Facility Name
University Hospital NANTES
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MICHEL, MD-PhD
Phone
+33240083475
Email
guillaume.michel@chu-nantes.fr
Facility Name
Hospital La Pitié Salpêtrière-APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele BERNARDESCHI, MD-PhD
Phone
+33142177440
Email
daniele.bernardeschi@aphp.fr
Facility Name
University Hospital TOURS
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles AUSSEDAT, MD-PhD
Phone
+33218370523
Email
c.aussedat@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
David BAKHOS, MD-PhD
Phone
+33218370523
Email
Bakhos.David@gmail.com
First Name & Middle Initial & Last Name & Degree
David BAKHOS, MD-PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Wicking for Ossicular Surgery and Myringoplasty
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