OBJECTIVE: To compare the efficacy of three surgical treatment combinations - myringotomy and tympanostomy tube insertion (M&T), adenoidectomy with M&T (A-M&T), and adenoidectomy with myringotomy (A-M) - in reducing middle-ear disease in young children with chronic OME. METHODS:Children 24-47 months of age, with a history of bilateral middle-ear effusion (MEE) for at least 3 months, unilateral for 6 months or longer or unilateral for 3 months after extrusion of a tympanostomy tube, unresponsive to recent antibiotic, were randomly assigned to either M&T, A-M&T, or A-M. Treatment assignment was stratified by age (24-35 months, 36-47 months), nasal obstruction (no, yes) and previous history of M&T (no, yes). Subjects were followed monthly and with any signs or symptoms of ear disease for up to 36 months. RESULTS:Ninety-eight subjects were randomly assigned to the three treatment groups. Fifty-six subjects (57%) were 24-35 months of age; 63% had nasal obstruction, and 36% had previously undergone M&T. During the 36 months after entry, subjects were noted to have MEE for the following percentages of time: 18.6% in the M&T group, 20.6% in the A-M&T group, and 31.1% in the A-M group (M&T vs. A-M&T, p=0.87; M&T vs. A-M, p=0.01). By 36 months, there were no differences in the number of further surgical procedures for ear disease needed among the groups. CONCLUSIONS:Adenoidectomy with or without tube insertion provided no advantage to young children with chronic OME in regard to time with effusion compared to tube insertion alone. Fewer tympanostomy tubes were placed in children undergoing A-M as their initial procedure, but this should be balanced by the performance of the more invasive surgical procedure and their increased time with effusion.
RCT Entities:
OBJECTIVE: To compare the efficacy of three surgical treatment combinations - myringotomy and tympanostomy tube insertion (M&T), adenoidectomy with M&T (A-M&T), and adenoidectomy with myringotomy (A-M) - in reducing middle-ear disease in young children with chronic OME. METHODS:Children 24-47 months of age, with a history of bilateral middle-ear effusion (MEE) for at least 3 months, unilateral for 6 months or longer or unilateral for 3 months after extrusion of a tympanostomy tube, unresponsive to recent antibiotic, were randomly assigned to either M&T, A-M&T, or A-M. Treatment assignment was stratified by age (24-35 months, 36-47 months), nasal obstruction (no, yes) and previous history of M&T (no, yes). Subjects were followed monthly and with any signs or symptoms of ear disease for up to 36 months. RESULTS: Ninety-eight subjects were randomly assigned to the three treatment groups. Fifty-six subjects (57%) were 24-35 months of age; 63% had nasal obstruction, and 36% had previously undergone M&T. During the 36 months after entry, subjects were noted to have MEE for the following percentages of time: 18.6% in the M&T group, 20.6% in the A-M&T group, and 31.1% in the A-M group (M&T vs. A-M&T, p=0.87; M&T vs. A-M, p=0.01). By 36 months, there were no differences in the number of further surgical procedures for ear disease needed among the groups. CONCLUSIONS: Adenoidectomy with or without tube insertion provided no advantage to young children with chronic OME in regard to time with effusion compared to tube insertion alone. Fewer tympanostomy tubes were placed in children undergoing A-M as their initial procedure, but this should be balanced by the performance of the more invasive surgical procedure and their increased time with effusion.
Authors: J L Paradise; C D Bluestone; K D Rogers; F H Taylor; D K Colborn; R Z Bachman; B S Bernard; R H Schwarzbach Journal: JAMA Date: 1990-04-18 Impact factor: 56.272
Authors: Maaike Ta van den Aardweg; Anne Gm Schilder; Ellen Herkert; Chantal Wb Boonacker; Maroeska M Rovers Journal: Cochrane Database Syst Rev Date: 2010-01-20
Authors: Ellen M Mandel; J Douglas Swarts; Margaretha L Casselbrant; Kathleen K Tekely; Beverly C Richert; James T Seroky; William J Doyle Journal: Laryngoscope Date: 2013-04-10 Impact factor: 3.325
Authors: Nicola L Harman; Iain A Bruce; Jamie J Kirkham; Stephanie Tierney; Peter Callery; Kevin O'Brien; Alex M D Bennett; Raouf Chorbachi; Per N Hall; Anne Harding-Bell; Victoria H Parfect; Nichola Rumsey; Debbie Sell; Ravi Sharma; Paula R Williamson Journal: PLoS One Date: 2015-06-26 Impact factor: 3.240