OBJECTIVES:Insertion of ventilation tubes in children with otitis media with effusion (OME) is an accepted and common treatment procedure. The majority of patients require general anesthesia. Although laser myringotomy can be performed in local anesthesia, evidence is lacking that this treatment modality is an alternative for tubes, and outcome predictors for laser myringotomy are not available. STUDY DESIGN: Prospective randomized trial. METHODS: We screened 1,403 children with chronic OME that were indicated for placement of ventilation tubes. In the eligible patients, we performed laser myringotomy in one ear and placed a tube in the other ear, both within the same patient. Follow-up was scheduled each month for 6 months. Success was defined as absence of effusion or aural discharge. A logistic regression model was used with success of the therapy as binary outcome. This model was based on base-line variables, asked for in a parent's questionnaire. RESULTS:Two hundred eight children received the allocated intervention, and no complications occurred. The mean closure time of the laser perforation was 2.4 weeks, and the mean patency time of the ventilation tube was 4.0 months. The mean success rate was 40% for laser and 78% for tubes. Ten known variables were found to predict middle ear status after therapy. CONCLUSION:Laser myringotomy is a safe but less-effective procedure than insertion of a ventilation tube in the treatment of chronic OME. The prognostic model enables the otolaryngologist to choose the surgical treatment for the child that benefits most: laser myringotomy or ventilation tube.
RCT Entities:
OBJECTIVES: Insertion of ventilation tubes in children with otitis media with effusion (OME) is an accepted and common treatment procedure. The majority of patients require general anesthesia. Although laser myringotomy can be performed in local anesthesia, evidence is lacking that this treatment modality is an alternative for tubes, and outcome predictors for laser myringotomy are not available. STUDY DESIGN: Prospective randomized trial. METHODS: We screened 1,403 children with chronic OME that were indicated for placement of ventilation tubes. In the eligible patients, we performed laser myringotomy in one ear and placed a tube in the other ear, both within the same patient. Follow-up was scheduled each month for 6 months. Success was defined as absence of effusion or aural discharge. A logistic regression model was used with success of the therapy as binary outcome. This model was based on base-line variables, asked for in a parent's questionnaire. RESULTS: Two hundred eight children received the allocated intervention, and no complications occurred. The mean closure time of the laser perforation was 2.4 weeks, and the mean patency time of the ventilation tube was 4.0 months. The mean success rate was 40% for laser and 78% for tubes. Ten known variables were found to predict middle ear status after therapy. CONCLUSION: Laser myringotomy is a safe but less-effective procedure than insertion of a ventilation tube in the treatment of chronic OME. The prognostic model enables the otolaryngologist to choose the surgical treatment for the child that benefits most: laser myringotomy or ventilation tube.