This retrospective cohort study followed STROBE guidelines. The patient
inclusion process is detailed in Figure 1. All
consecutive patients, aged < 18 years old, operated on between
January 1998 and December 2012 for tympanic membrane (TM) perforation
closure using a cartilage underlay technique were included. Patients had
to have a one-year follow-up (including anatomical examination and
audiometry workup) and have no history of ipsilateral ear surgery
(except for ventilation tubes). Medical files of all perforations were
reviewed using FileMaker Pro (Claris, Santa Clara, California, USA) and
per, perioperative and surgical data was analysed. Patient age at
surgery, sex and comorbidities (allergy, cleft palate, craniofacial
anomaly) were noted. Also, perforation size, location, surgical
technique, expertise of the surgeon (junior surgeon or senior paediatric
otologist), status of the contralateral ear and perioperative
observations (mucosa inflammation, glue in the middle ear) were noted.
The following postoperative information was noted: TM closure,
myringitis, otitis media with effusion (OME), TM retraction,
cholesteatoma, external auditory canal stenosis. Audiometric tests, air
and bone conduction, mean air-bone gap, were reported using the
pure-tone average (PTA) referring to the average of hearing threshold
levels at 500, 1000, 2000 and 4000Hz.
Statistical analysis was made using R software
(http://cran.r-project.org/). Data was described as mean ±
standard deviation or median [interquartile range] for quantitative
variables and frequencies (%) for qualitative variables. Comparisons
for continuous data were performed through Student test or Wilcoxon rank
test and for categorical data through Pearson’s Chi-squared test or
Fisher’s Exact Test. Statistical tests were two-sided and p values less
than 0.05 were considered statistically significant.
This is a retrospective study and has been approved by our local
Institution Review Board (IRB). The study was registered on the Clinical
Trials Database (NCT02296944). In compliance with French law, a letter
of no objection was sent to all participants if they were adults or
otherwise their parents. The data that support the findings of this
study are available on request from the corresponding author. The data
are not publicly available due to privacy or ethical restrictions.