A randomized prospective trial of a novel device for measuring perforation size during inlay 'butterfly' myringoplasty

Abstract

Aim: This study introduces a new device to facilitate perforation size measurement during "butterfly" myringoplasty. The purpose of this study is to evaluate the use of 'otological compass' on short-term results of inlay cartilaginous 'butterfly' tympanoplasty technique in adult patients.

Study design: Prospective, randomized, controlled, blinded.

Patients and methods: This study included 25 patients who underwent inlay cartilage myringoplasty. All operations were performed under general anesthesia by the same surgeon with a microscope-assisted approach. The patients were divided randomly and consecutively into two groups: Group 1 (n=12) had perforation dimensions and shape measured using the Otologic Compass (OC) and the control group (n=13) had perforation measured by means of a Fisch elevator. The duration of surgery, number of trials for correct placement of the cartilage graft, results and complications of the surgery were evaluated and compared.

Results: The mean follow-up duration was 6 months. Groups were similar in terms of age and perforation diameters (p>0.05). Average number of cartilage shaping before satisfactory graft fitting was significantly fewer in the OC group: 1.1 ± 0.3 and 2.2 ± 0.6 trials for OC and control groups, respectively (p<0.001). Mean duration of preparation and satisfactory graft fitting was 9.6 ± 4.2 minutes in the OC group whereas it was 18.1 ± 5.2 minutes for the control group. Operative duration was significantly shorter in the OC group (p<0.001). At the end of the follow-up period, successful closure occurred 91.7% and 84.6% patients in the OC and control groups, respectively (p>0.05). The mean preoperative to postoperative three-tone air-bone gap improved 7.9 dB and 9.0 dB in OC and control groups, respectively (p>0.05).

Conclusion: This study shows that OC presents as a useful tool that expedites and refines butterfly myringoplasty procedure. The number of cartilage shaping prior to satisfactory graft fitting revealed significantly better results: almost all surgeries in the OC group were complete after a single cartilage shaping attempt.