Mohammad Faramarzi1, Sareh Roosta1, Safoura Aminpour2. 1. Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 2. Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.
Abstract
OBJECTIVES: One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot and soft connective tissue. Up to now, there has been no randomised clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material. DESIGN: This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy. SETTING:Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran. PARTICIPANTS: A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears. MAIN OUTCOME MEASURES: Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated. RESULTS: Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative air-bone gap (ABG) within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P > 0.05). In addition, there was no case of dead ear in either group. CONCLUSIONS: We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short-term follow-up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.
RCT Entities:
OBJECTIVES: One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot and soft connective tissue. Up to now, there has been no randomised clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material. DESIGN: This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy. SETTING: Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran. PARTICIPANTS: A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears. MAIN OUTCOME MEASURES: Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated. RESULTS: Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative air-bone gap (ABG) within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P > 0.05). In addition, there was no case of dead ear in either group. CONCLUSIONS: We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short-term follow-up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.
Authors: Alfonso Scarpa; Pasquale Marra; Massimo Ralli; Pasquale Viola; Federico Maria Gioacchini; Giuseppe Chiarella; Francesco Antonio Salzano; Pietro De Luca; Filippo Ricciardiello; Claudia Cassandro; Grazia Maria Corbi Journal: Eur Arch Otorhinolaryngol Date: 2022-07-20 Impact factor: 3.236