Riccardo D'Eredità1, Marko B Lens. 1. Department of Otolaryngology-Head and Neck Surgery, Division of Pediatric Otolaryngology, Vicenza Civil Hospital, Vicenza, Italy. riccardo.deredita@ulssvicenza.it
Abstract
OBJECTIVES:Tympanic membrane (TM) perforation closure can present a problem in children, especially in anterior and total perforations, because of the anterior's lack of support for the graft. It was suggested that the anterior tab flap (ATF) myringoplasty, an underlay graft with an anterior tab under the TM annulus, could provide better stability of the graft. We undertook a prospective, randomized, controlled study to compare the ATF myringoplasty with the standard underlay (SU) myringoplasty in children. METHODS: We randomly assigned 59 children to undergo ATF myringoplasty and 52 to undergo SU myringoplasty at a tertiary care pediatric institution. Surgery was performed under general anesthesia in all patients. The primary outcome was the healing of the TM; the secondary outcomes were anterior blunting of the graft and presence of retraction of the TM. Two years of follow-up were obtained in all enrolled children. RESULTS: At 2 years of follow-up, there were 55 stable TM closures in the ATF arm and 44 in the SU arm. Although the TM closure was higher in the ATF arm than in the SU arm (93.2 and 84.6%, respectively), the results were not statistically significant (odds ratio = 0.4, 95% confidence interval = 0.12-1.41). Anterior blunting and TM retraction were not encountered. CONCLUSION: The ATF myringoplasty is a safe and effective method for TM closure in children. However, compared with the SU myringoplasty, the ATF myringoplasty is not associated with an overall decrease in the incidence of the residual perforations. Further assessment in a larger study is proposed.
RCT Entities:
OBJECTIVES: Tympanic membrane (TM) perforation closure can present a problem in children, especially in anterior and total perforations, because of the anterior's lack of support for the graft. It was suggested that the anterior tab flap (ATF) myringoplasty, an underlay graft with an anterior tab under the TM annulus, could provide better stability of the graft. We undertook a prospective, randomized, controlled study to compare the ATF myringoplasty with the standard underlay (SU) myringoplasty in children. METHODS: We randomly assigned 59 children to undergo ATF myringoplasty and 52 to undergo SU myringoplasty at a tertiary care pediatric institution. Surgery was performed under general anesthesia in all patients. The primary outcome was the healing of the TM; the secondary outcomes were anterior blunting of the graft and presence of retraction of the TM. Two years of follow-up were obtained in all enrolled children. RESULTS: At 2 years of follow-up, there were 55 stable TM closures in the ATF arm and 44 in the SU arm. Although the TM closure was higher in the ATF arm than in the SU arm (93.2 and 84.6%, respectively), the results were not statistically significant (odds ratio = 0.4, 95% confidence interval = 0.12-1.41). Anterior blunting and TM retraction were not encountered. CONCLUSION: The ATF myringoplasty is a safe and effective method for TM closure in children. However, compared with the SU myringoplasty, the ATF myringoplasty is not associated with an overall decrease in the incidence of the residual perforations. Further assessment in a larger study is proposed.