Ventilation tubes in secretory otitis media. A randomized, controlled study of the course, the complications, and the sequelae of ventilation tubes.

The purpose of this study has been to evaluate the use of ventilation tubes in the treatment of cases of primary secretory otitis media. Bilateral cases were selected and a tube inserted in one ear while the other ear was left intact. Adenoidectomy was performed on all children, tonsillectomy in 34% of the cases. A total of 150 children (mean age = 3.9 years) were included during the years 1976-1979 and check-ups performed every 3-6 months. The follow-up rate was 89.3%. The condition of each individual was assessed after a 5-year period, the mean period of observation was 3.2 years. The results of tympanometry and audiometry from the two types of ears were, on average, similar. Repeat operation was carried out in 17% of the cases and later otomicroscopy revealed a higher incidence of atrophy in these eardrums (p less than 0.01). A period of suppuration was noted in 25% of the ears with a ventilation tube, 2 months or more after operation; a higher incidence of tympanosclerosis was later found (p = 0.02). Twentythree per cent of the treated eardrums were characterized at the final check-up as "normal" by means of otomicroscopy, in contrast to 83% of the intact ears. The "end-result" of each ear was estimated using tympanometry, audiometry as well as otomicroscopy, and a difference in favour of the intact ears was found (p less than 0.01). A similar estimate for each child gave the result that 31% had one ear categorized as "pathological" while this was the case in both ears of 9% of the children. The children subjected to initial tonsillectomy showed a worse "end-result" (p less than 0.05). It is concluded that the use of ventilation tubes in children with primary secretory otitis media is not justified. Observation has shown that only a small proportion will require surgical treatment of the middle ear. A ventilation tube may be indicated in order to combat hearing loss, but it should be borne in mind that its use involves a high risk of complications and sequelae which may result in chronic middle ear disease.

RCT Entities:   Population Interventions Outcomes