Comparison of tympanoplasty surgery outcome using amniotic membrane and autologous temporalis fascia: A randomized controlled trial study

Publish Year: 1397
نوع سند: مقاله کنفرانسی
زبان: English
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AMSMED19_053

تاریخ نمایه سازی: 1 دی 1397

Abstract:

Background and Objective: The separates the middle and the external ear canal. While TM has the ability of spontaneously healing. Chronic perforation of TM in the absence of its spontaneously healing indicates surgical management. It has proven that using different materials results in various outcome and postoperative complications. The human amniotic membrane is preservable. Also, there is not significant immunologic reactions against such graft material The aim of current study is to compare the outcome of surgical reconstruction of the TM using membrane amniotic and surgical tympanoplasty with autologous fascia. Materials and Methods: This clinical trial study was conducted on the patients who underwent tympanoplasty surgery at Baqiyatallah Hospital in 2017. The patients were assessed in aspect of complications and surgical outcome. Post-operative follow ups at three days, two weeks, one month, and three months after surgery were conducted. Sample size calculated by distribution of similar articles. The exclusion criteria includes acute otorrhea, cholesteatoma, canal stenosis requiring canaloplasty, Immunocompromised patients, Diabetes mellitus, Perforations less than one fifth area of the TM, and Smoking. The number of 30 patients selected to the study and were compared in two groups randomly. Demographic information and surgery outcomes entered into an analytic software and analyzed blindly. Data were analyzed using IBM SPSS Statistics for Windows (version 21, IBM Corp, Armonk, NY). The frequency of each variable determined by the statistic frequency program. The groups were compared using student t-test and Chi-Square. The P-value less than 0.05 considered statistically significant. Indeed, the study approved in Baqiyatallah ethics committee (ethics code: Ir.bmsu.rec.1395.233) and the clinical trial code is NCT03569969 Results: The number of 30 patients enrolled in the study and were compared in two groups. The success rate of surgery in amniotic membrane and temporalis fascia results is 14.2 % and 66.6%, respectively. Mean perforation size was not statistically significant difference in both groups (P= 0.918) .Mild hearing loss and the other complications such as inflammation and infection represented in about 12 (85%) surgeries in the case group and only 2 (14%) cases resulted in improving hearing. the short duration of surgery is one of the advantages in the case group than control (P value= 0.024), but nevertheless, There is twice as many success as failure in control group. So, There is a significant relationship between autologous facial membrane and Human amniotic membrane (P= 0.019) Conclusion: While previous studies have introduced amniotic membrane as beneficial dressing material in many surgeries and results in reduction of healing and surgery duration. But according to high complications and failure rate in the study, using amniotic membrane as a graft material is not recommended.

Authors

Amirhossein Komijani

Otorhinolaryngology Department, Baqiyatallah University of Medical Sciences, Tehran, Iran

masoumeh saeedi

Neurotology and Skull Base Surgery, Otorhinolaryngology Department, Baqiyatallah University of Medical Sciences, Tehran, Iran

Mohammad Sadegh Bagheri-baghdasht

Students’ Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran

Shahriar Najafizadeh-Sari

International Otorhinolaryngology Research Association (IORA), Universal Scientific and Education Research Network (USERN), Tehran, Iran