Surgery for the treatment of Otitis Media in Indigenous children, surgical sub-study

Comparison of outcomes of 2 surgical techniques in Indigenous children with OM living in remote communities. Arm 1: bilateral myringotomy with adenoidectomy Arm 2: bilateral grommet tube insertion and adenoidectomy Both surgical interventions are performed once only under general anaesthetic according to standard, current surgical protocols and each routinely take less than 30 minutes. Surgery is performed by ENT specialists. There is nothing novel involved with these procedures. The study objective is to compare the outcomes of current interventions after 12 months. The target group is the same as the original study, ie Indigenous children aged 3-10 yrs who have chronic otitis media. The reason for the change was that North Queensland paediatricians believe that by the time surgery is recommended in Qld, the children have already undergone a supervised period of medical treatment to a degree not seen elsewhere in the country. However, there was an interest in Qld in addressing the surgical questions raised in this Trial. The redesigned project has been divided into 2 parts, 1. Surgery V surgery substudy – 280 children across NT / WA and North Qld. 2. Surgery v medical care substudy – 200 children in NT & WA only The total number of children (480) remains the same as originally proposed. The total number of children whose data will be analysed to compare the 2 surgeries is therefore 380. This comprises 280 from surgical sub-study and 100 from the surgical arm of the medical / surgical sub-study. The data from both studies will be entered into a common database.