There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material. No-one knows if there are differences between the different kinds of tubes regarding complications. The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications. To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear. The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested. The first combination will test: "Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone) The second combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone) The third combination will test: "Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone) The fourth combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)
Danderyds Hospital
Stockholm, Stockholm County, Sweden
Time to complete expulsion of the ventilation tube from the tympanic membrane
Time frame: 45 months
Persistent tympanic membrane perforation
Time frame: 45 months
Need for tube extraction (pain or infection)
Time frame: 45 months
Pain leading to health care contact
Time frame: 45 months
Tube related ear infection
Time frame: 45 months
Obstruction of the tube
Time frame: 45 months
Presence of myringosclerosis
Time frame: 45 months
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