The long-term effect of unilateral t-tube insertion in patients undergoing cleft palate repair: 20-year follow-up of a randomised controlled trial.

OBJECTIVES: Between July 1984 and March 1987, all children that underwent repair for primary cleft palate at the Queen Victoria Hospital were enrolled in a clinical trial. Those found to have otitis media with effusion at time of surgery had a t-tube inserted into one randomised ear, whilst the other ear received no treatment. The object of the study was to reassess the patients from the original trial to discover the impact of the unilateral t-tube, twenty years later analysed on an intention to treat basis.

DESIGN: Children that underwent primary palatal closure during the study dates were identified from the cleft palate database. Patients that were involved in the original trial were identified, contacted and invited to take part in the follow-up study.

SETTING: Tertiary referral Specialist unit.

PARTICIPANTS: Twenty-two patients were identified as potential study participants. Of this group, fourteen were contactable and seven participants agreed to take part in our follow-up study.

MAIN OUTCOME MEASURES: Persistent symptomatology, otoscopy, pure tone audiometry and tympanometry.

RESULTS: Follow-up results were compared within the original treatment groups from the primary study, on an intention to treat basis. Otoscopically the ears were normal in 2 of the 7 treated ears compared with four of the seven non-treated ears. All the other ear ears had various types of chronic otitis media. Four of the seven had hearing of >10 dB in the treated ear compared with the non-treated ear.

CONCLUSIONS: These findings would indicate need for caution in the use of t-tubes in the cleft population and raises the question of long-term follow-up to assess for secondary cholesteatoma.