Yu Si1, Yubin Chen2, Guo Xu3, Ximing Chen1, Wuhui He1, Zhigang Zhang1. 1. Department of Otolaryngology-Head and Neck Surgery , Sun Yat-Sen Memorial Hospital, and Institute of Hearing and Speech-Language Science, Sun Yat-sen University, Guangzhou, China. 2. Department of Otolaryngology-Head and Neck Surgery, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. 3. Department of Otolaryngology-Head and Neck Surgery, Shenzhen Children's Hospital, Shenzhen, China.
Abstract
OBJECTIVES/HYPOTHESIS: To investigate the simultaneous application of cartilage tympanoplasty combined with eustachian tube (ET) balloon dilatation in the treatment of adhesive otitis media (AdOM). STUDY DESIGN: Multicenter, prospective, double-blind, randomized, controlled clinical trial. METHODS:Patients with AdOM were randomly divided into four groups: control group (conservative treatment), ET balloon dilatation (ETBD) group, cartilage tympanoplasty (CT) group, and cartilage tympanoplasty combined with ET balloon dilatation (ETBD+CT) group. Patients were followed up at 3 months, 6 months, 1 year, and 2 years after treatment, receiving otoendoscopy and pure-tone audiometry, and were evaluated using the Tinnitus Handicap Inventory (THI), visual analogue scale (VAS) for the symptom of ear stuffiness, Chronic Otitis Media Outcome Test (COMOT-15), and eustachian tube scores (ETS). RESULTS: There was no improvement in tympanic membrane (TM) morphology and mean pure-tone air-bone gap (ABG) after treatment in the control and ETBD groups. The postoperative TM morphology was improved in the CT group and ETBD+CT group, although retraction pockets reoccurred in two cases of CT group. Reduced ABG and improvements in ETS, THI, VAS, and COMOT-15 were all achieved in these two groups, but the difference was not statistically significant. CONCLUSIONS:Cartilage tympanoplasty combined with ET balloon dilatation could be used as an appropriate surgical technique for AdOM, which could relieve the symptoms of tinnitus and ear stuffiness, and improve postoperative TM morphology, hearing level, ET functions, and quality of life, with low incidence of complications. LEVEL OF EVIDENCE: 2 Laryngoscope, 129:1462-1467, 2019.
RCT Entities:
OBJECTIVES/HYPOTHESIS: To investigate the simultaneous application of cartilage tympanoplasty combined with eustachian tube (ET) balloon dilatation in the treatment of adhesive otitis media (AdOM). STUDY DESIGN: Multicenter, prospective, double-blind, randomized, controlled clinical trial. METHODS:Patients with AdOM were randomly divided into four groups: control group (conservative treatment), ET balloon dilatation (ETBD) group, cartilage tympanoplasty (CT) group, and cartilage tympanoplasty combined with ET balloon dilatation (ETBD+CT) group. Patients were followed up at 3 months, 6 months, 1 year, and 2 years after treatment, receiving otoendoscopy and pure-tone audiometry, and were evaluated using the Tinnitus Handicap Inventory (THI), visual analogue scale (VAS) for the symptom of ear stuffiness, Chronic Otitis Media Outcome Test (COMOT-15), and eustachian tube scores (ETS). RESULTS: There was no improvement in tympanic membrane (TM) morphology and mean pure-tone air-bone gap (ABG) after treatment in the control and ETBD groups. The postoperative TM morphology was improved in the CT group and ETBD+CT group, although retraction pockets reoccurred in two cases of CT group. Reduced ABG and improvements in ETS, THI, VAS, and COMOT-15 were all achieved in these two groups, but the difference was not statistically significant. CONCLUSIONS:Cartilage tympanoplasty combined with ET balloon dilatation could be used as an appropriate surgical technique for AdOM, which could relieve the symptoms of tinnitus and ear stuffiness, and improve postoperative TM morphology, hearing level, ET functions, and quality of life, with low incidence of complications. LEVEL OF EVIDENCE: 2 Laryngoscope, 129:1462-1467, 2019.
Authors: Angelo Immordino; Federico Sireci; Francesco Lorusso; Francesco Martines; Francesco Dispenza Journal: Int Arch Otorhinolaryngol Date: 2022-01-28