A randomized controlled trial comparing the outcomes of endoscopic total annular excision tympanoplasty and conventional tympanoplasty
摘要
To compare the outcomes of conventional tympanoplasty and endoscopic total annular excision tympanoplasty in chronic otitis media (COM) mucosal type with large and subtotal perforations; in terms of graft uptake and hearing improvement.
MethodsStudy design: Single blinded RCT.
Setting: Department of ENT at AIIMS Bhubaneswar, India.
The study was a single-blinded RCT done in patients of COM mucosal type, attending the Department of ENT at our Institute, during the period of January,2022 to March,2023. Patients with subtotal perforation with an Air Bone gap (AB gap) of > / = 20 deciBel (dB) were included in the study. They were divided into 2 arms of 30 patients each, one group underwent a conventional tympanoplasty while the other group had an endoscopic total annular excision (TAE) tympanoplasty. Graft uptake was measured by otoendoscopy at 6 months and 34 months postoperatively, hearing gain by Pure Tone Audiometry (PTA) and patient satisfaction by Chronic Ear Survey to asses quality of life.
ResultsThere was no significant difference among the groups in terms of age, gender, occupation, or socioeconomic status. The median preoperative Air conduction (AC), Bone conduction (BC), AB gap or Speech reception threshold were also not significantly different among the groups. 25 patients (83.3%) of TAE had an intact neotympanum, compared to 24(80%) in the control group(p-value = 0.565). The patients who underwent TAE tympanoplasty had a median reduction in Air–Bone gap of 12.50 dB, while those in the conventional tympanoplasty group had a median reduction of 8.0 dB (p value = 0.011). The median postoperative Speech Reception Threshold (SRT) in the TAE tympanoplasty group was 35.00, whereas in the control group it was 40.00 (p value = 0.009).
ConclusionTAE tympanoplasty is a safe and effective surgery for mucosal type of chronic otitis media with subtotal perforation, and correlates clinically. TAE tympanoplasty showed better improvement in AB gap and postop SRT.