BACKGROUND: The tympanoplasty for high-risk tympanic membrane perforation is a challenge. It is necessary to compare the most useful and feasible surgical technics in our environment for these patients. The objective was to compare the cartilage island tympanoplasty for the treatment of high-risk tympanic membrane perforations versus the use of temporalis fascia. METHODS: Randomized controlled clinical trial in 69 patients of ten years or older, diagnosed with high-risk tympanic membrane perforation in a third level hospital. The MERI index was determined and an initial audiometry was obtained. 7, 30 and 60 days after the tympanoplasty the tympanic graft integrity was evaluated. The audiometry was only repeated at 60 days. RESULTS:69 patients were included, 33 received cartilage island (group 1) and 36 temporalis fascia (group 2). 93.9% was the success rate for group 1 at 30 and 60 days and 83.3% for group 2 (p = 0.17). Hearing improvement was neither different between groups (33.1 vs. 33.6 dB; p = 0.88), for group 1 and 2, respectively. CONCLUSION: No difference in morphological and audiological outcomes using cartilage island tympanoplasty or temporalis fascia for the treatment of high-risk tympanic membrane perforation was found.
RCT Entities:
BACKGROUND: The tympanoplasty for high-risk tympanic membrane perforation is a challenge. It is necessary to compare the most useful and feasible surgical technics in our environment for these patients. The objective was to compare the cartilage island tympanoplasty for the treatment of high-risk tympanic membrane perforations versus the use of temporalis fascia. METHODS: Randomized controlled clinical trial in 69 patients of ten years or older, diagnosed with high-risk tympanic membrane perforation in a third level hospital. The MERI index was determined and an initial audiometry was obtained. 7, 30 and 60 days after the tympanoplasty the tympanic graft integrity was evaluated. The audiometry was only repeated at 60 days. RESULTS: 69 patients were included, 33 received cartilage island (group 1) and 36 temporalis fascia (group 2). 93.9% was the success rate for group 1 at 30 and 60 days and 83.3% for group 2 (p = 0.17). Hearing improvement was neither different between groups (33.1 vs. 33.6 dB; p = 0.88), for group 1 and 2, respectively. CONCLUSION: No difference in morphological and audiological outcomes using cartilage island tympanoplasty or temporalis fascia for the treatment of high-risk tympanic membrane perforation was found.