Mohammad Faramarzi1,2, Sareh Roosta2, Ali Faramarzi3,4, Mohammad Ali Asadi2. 1. Department of Otorhinolaryngology-Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran. 2. Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 3. Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. ali_faramarzi@sums.ac.ir. 4. Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. ali_faramarzi@sums.ac.ir.
Abstract
PURPOSE: In the literature on stapes surgery, various materials have been used to seal the vestibulotomy. To date, there are only a few published randomized clinical trials with focus on hearing outcomes, using different sealing materials. Hence, the aim of this study was to compare hearing outcomes when using fat or Hyaluronic acid gel (HAG) to seal the stapedotomy. METHODS: The present double-blind, prospective, randomized clinical trial was conducted on ears undergoing stapedotomy in Dasthgheib Hospital, a referral otology center in Southern Iran, and Dena private hospital, Shiraz Iran. A total of 150 primary stapedotomies were evaluated, and sealing material was fat in 77 ears and HAG in 73. RESULTS: 60 (77.9%) of the fat group ears and 63 (86.3%) of the HAG group ears obtained postoperative air-bone gap (ABG) within 20 dB, but the difference was not significant (p = 0.182). CONCLUSION: As a sealing material in stapedotomy, HAG is comparable with fat in terms of hearing outcomes. Therefore, HAG is recommended as a safe sealing material in stapedotomy.
RCT Entities:
PURPOSE: In the literature on stapes surgery, various materials have been used to seal the vestibulotomy. To date, there are only a few published randomized clinical trials with focus on hearing outcomes, using different sealing materials. Hence, the aim of this study was to compare hearing outcomes when using fat or Hyaluronic acid gel (HAG) to seal the stapedotomy. METHODS: The present double-blind, prospective, randomized clinical trial was conducted on ears undergoing stapedotomy in Dasthgheib Hospital, a referral otology center in Southern Iran, and Dena private hospital, Shiraz Iran. A total of 150 primary stapedotomies were evaluated, and sealing material was fat in 77 ears and HAG in 73. RESULTS: 60 (77.9%) of the fat group ears and 63 (86.3%) of the HAG group ears obtained postoperative air-bone gap (ABG) within 20 dB, but the difference was not significant (p = 0.182). CONCLUSION: As a sealing material in stapedotomy, HAG is comparable with fat in terms of hearing outcomes. Therefore, HAG is recommended as a safe sealing material in stapedotomy.
Entities:
Keywords:
Fat; Hyaluronic acid; Otosclerosis; Sealing material; Stapedotomy; Stapes surgery
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