Predictive factors of successful tympanoplasty and quality of life outcomes in adults with dry perforation: a randomised clinical trial

Understanding clinical outcomes following tympanoplasty is essential for effectively counseling patients and providing a comprehensive perspective on its benefits and limitations. To evaluate the effects of tympanoplasty on ear-related clinical symptoms, hearing function, health-related quality of life (HRQol), and symptoms of depression and anxiety. A randomized, non-blinded clinical trial was conducted. Patients scheduled for tympanoplasty were compared with a control group of individuals on the surgical waiting list. A single academic tertiary care center. The study included 111 participants (41 males [36.94%], 70 females [63.06%]; mean age = 34.41 ± 12.78 years) with dry tympanic membrane perforations. Among them, 63 underwent tympanoplasty, with success and failure rates of 33:18 (64.71%: 35.29%) at 3 months, and 22:16 (57.89%: 42.11%) at 6 months. The remaining 48 served as controls, with 43 (89.58%) followed up at 3 months. Tympanoplasty was evaluated at three time points-preoperatively (T0), and postoperatively at 3 months (T3) and 6 months (T6). Primary outcomes included scores from the Arabic version of the Ear Outcome Survey-16 (EOS-16) and the Arabic Version of the Hospital Anxiety and Depression Scale (HADS), assessed at T0, T3, and T6. For successful tympanoplasty: the Overall_Q1-14 score ((30.41 ± 12.09), (15.36 ± 6.97) and (15.55 ± 6.88), n = 22, p < 0.001), for failed tympanoplasty: the Overall_Q1-14 score ((25.69 ± 11.84), (21.94 ± 9.81) and (21.31 ± 11.85), n = 16, p = 0.3) and for controls: the Overall_Q1-14 score ((27.02 ± 12.88) and (26.49 ± 13.26), n = 43, p = 0.59). Almost all distinct items showed statistical significance p < 0.05 after successful tympanoplasty against none after failure tympanoplasty while controls remained unchanged. Multiple linear regression equation of depression score (T3-T0) in successful tympanoplasty "Y_depression = (2.44 + 0.162x_Overall + 0.156x_AC) + Ɛ_depression". Successful tympanoplasty significantly improved ear symptoms, hearing function, psychosocial well-being, and overall health-related quality of life. Although it had no immediate or direct effect on depression or anxiety, improvements in hearing and quality of life were predictive of reductions in depressive symptoms. These findings highlight the broader psychosocial benefits of tympanoplasty and support its role in holistic patient care.Trial registration This study was registered with ANZCTR (ACTRN12625000436471) on 09/05/2025.