J W Loock1, N Naude. 1. Department of Otorhinolaryngology, University of Stellenbosch, Cape Town, South Africa. jwl@sun.ac.za
Abstract
OBJECTIVES: To determine whether the way in which temporalis fascia is treated during myringoplasty affects the rate of successful perforation closure. DESIGN: A randomised controlled trial. SETTING: A tertiary ENT Department within the Tygerberg Academic Hospital. PARTICIPANTS: One hundred and fifty patients with perforations between 30% and 70% of the surface area of the eardrum undergoing elective myringoplasty were randomised into three groups by the way in which the temporalis fascia used was treated prior to insertion: fresh fascia; dried fascia; and fascia which was dried and then rehydrated. MAIN OUTCOME MEASURES: The outcome measure was intactness of the tympanic membrane 6 weeks after surgery. Preoperative and follow-up audiometry was obtained, but was not evaluated as an outcome measure. RESULTS:Successful closure of the perforation was achieved in 89% in the dried fascia group (42 of 47 patients), 84% in the fresh fascia group (37 of 44 patients), and 85% in the dried and rehydrated group (39 of 46 patients). The study showed no statistically significant difference between the three groups (P = 0.728). The study would have to had more than 800 patients in each group to have the power to show a 5% difference in take rates. CONCLUSIONS: While the dessication of temporalis fascia prior to use in myringoplasy results in degeneration of cellular and stromal elements histologically, this does not affect the successful closure of perforations. Clinicians should feel free to prepare the fascia in whichever way they find easiest to work with.
RCT Entities:
OBJECTIVES: To determine whether the way in which temporalis fascia is treated during myringoplasty affects the rate of successful perforation closure. DESIGN: A randomised controlled trial. SETTING: A tertiary ENT Department within the Tygerberg Academic Hospital. PARTICIPANTS: One hundred and fifty patients with perforations between 30% and 70% of the surface area of the eardrum undergoing elective myringoplasty were randomised into three groups by the way in which the temporalis fascia used was treated prior to insertion: fresh fascia; dried fascia; and fascia which was dried and then rehydrated. MAIN OUTCOME MEASURES: The outcome measure was intactness of the tympanic membrane 6 weeks after surgery. Preoperative and follow-up audiometry was obtained, but was not evaluated as an outcome measure. RESULTS: Successful closure of the perforation was achieved in 89% in the dried fascia group (42 of 47 patients), 84% in the fresh fascia group (37 of 44 patients), and 85% in the dried and rehydrated group (39 of 46 patients). The study showed no statistically significant difference between the three groups (P = 0.728). The study would have to had more than 800 patients in each group to have the power to show a 5% difference in take rates. CONCLUSIONS: While the dessication of temporalis fascia prior to use in myringoplasy results in degeneration of cellular and stromal elements histologically, this does not affect the successful closure of perforations. Clinicians should feel free to prepare the fascia in whichever way they find easiest to work with.