Ejder Ciğer1, Mustafa Koray Balcı2, Akif İşlek1, Kazım Önal1. 1. Department of Otorhinolaryngology, İzmir Katip Çelebi University Atatürk Training and Research Hospital, 35170, Izmir, Turkey. 2. Department of Otorhinolaryngology, İzmir Katip Çelebi University Atatürk Training and Research Hospital, 35170, Izmir, Turkey. m.koray.balci@gmail.com.
Abstract
OBJECTIVES: To compare the anatomical and functional outcomes of two different grafts which are used for the reconstruction of subtotal or total tympanic membrane perforations: the wheel-shaped composite cartilage graft (WsCCG) and temporalis fascia (TF). METHODS:Ninety patients (94 ears) who underwent type 1 tympanoplasty for non-complicated chronic otitis media between March 2014 and June 2016 in a tertiary referral center were included in a randomized, controlled, prospective clinical trial. Tympanic membranes were reconstructed with the WsCCG or TF. RESULTS: Outcomes of 91 surgeries performed on 87 adults (> 18 years of age) were evaluated in the study. Forty-three patients (44 ears) were included in the WsCCG group; 44 patients (47 ears) were included in the TF group. The mean post-operative follow-up was 14.9 months for the WsCCG group and 15.1 months for the TF group. There was no statistically significant difference in post-operative pure tone average (PTA) (p = 0.19), air-bone gap (ABG) (p = 0.64), PTA gain (p = 0.82) and ABG closure (p = 0.89) values between two groups. Graft success rates at 6 months after surgery were 82.9% (39/47) and 97.7% (43/44) for TF and WsCCG, respectively. At the first year, success rates were 85.1% (40/47) for TF and 97.7% (43/44) for WsCCG. A statistically significant difference was observed in graft success rates between two groups (p = 0.039). CONCLUSIONS: Both TF and WsCCG lead to satisfactory functional results, but the WsCCG clearly leads to superior anatomical outcomes with a graft success rate of 97.7%. The WsCCG is a suitable graft for subtotal or total tympanic membrane perforations and has the advantages of being a one-piece, flexible, composite, and physically resistant graft.
RCT Entities:
OBJECTIVES: To compare the anatomical and functional outcomes of two different grafts which are used for the reconstruction of subtotal or total tympanic membrane perforations: the wheel-shaped composite cartilage graft (WsCCG) and temporalis fascia (TF). METHODS: Ninety patients (94 ears) who underwent type 1 tympanoplasty for non-complicated chronic otitis media between March 2014 and June 2016 in a tertiary referral center were included in a randomized, controlled, prospective clinical trial. Tympanic membranes were reconstructed with the WsCCG or TF. RESULTS: Outcomes of 91 surgeries performed on 87 adults (> 18 years of age) were evaluated in the study. Forty-three patients (44 ears) were included in the WsCCG group; 44 patients (47 ears) were included in the TF group. The mean post-operative follow-up was 14.9 months for the WsCCG group and 15.1 months for the TF group. There was no statistically significant difference in post-operative pure tone average (PTA) (p = 0.19), air-bone gap (ABG) (p = 0.64), PTA gain (p = 0.82) and ABG closure (p = 0.89) values between two groups. Graft success rates at 6 months after surgery were 82.9% (39/47) and 97.7% (43/44) for TF and WsCCG, respectively. At the first year, success rates were 85.1% (40/47) for TF and 97.7% (43/44) for WsCCG. A statistically significant difference was observed in graft success rates between two groups (p = 0.039). CONCLUSIONS: Both TF and WsCCG lead to satisfactory functional results, but the WsCCG clearly leads to superior anatomical outcomes with a graft success rate of 97.7%. The WsCCG is a suitable graft for subtotal or total tympanic membrane perforations and has the advantages of being a one-piece, flexible, composite, and physically resistant graft.