Comparing Gelfoam vs fat as a sealing material in stapedotomy: A prospective double-blind randomised clinical trial.

Abstract

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. This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy. Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran. A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears. Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated. 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 20dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3kHz. There were 9 cases of sensorineural hearing loss at 4kHz 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. 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.