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.



Introduction


The main objective of tympanic membrane perforation (TMP) repair is total and definitive closure of the perforation and hearing improvement. Myringoplasty is the operation to fulfill these aims. In 1998, Eavey introduced cartilage, perichondrium butterfly inlay tympanoplasty technique for closure of small to medium sized central perforations . This technique does not necessitate tympanomeatal flap elevation, can be carried out under local anesthesia, minimal scarring associated with transcanal approach and postoperative care and follow-up is not complex and can be easily and cost effectively applied transcanally compared to inlay and underlay tympanoplasty techniques .


There are two main challenges associated with transcanal “butterfly” inlay myringoplasty: precise evaluation of the perforation size and meticulous preparation of an accurately fitting cartilage graft. These two factors are determining factors for obtaining successful surgical outcomes. The current article presents the results of 25 consecutive transcanal inlay cartilaginous myringoplasties and introduces a novel device, namely Otologic Compass (OC) (patent pending), for correct close-up measuring TMP size. Aim of the present study is to evaluate the effect of OC on precise graft preparation and positioning by means of operative time, number of trials for graft positioning and operative outcome.





Patients and methods


This study included patients of older than 15 years old, with TMP caused by mesotympanic chronic otitis media. A local antibiotic and steroid treatment was performed to eradicate preoperative inflammation of the tympanic cavity. Both microscope and endoscope-assisted otoscopy (Karl Storz rigid 0° degree endoscope, 4 mm diameter) were carried out determining the features of the perforation. Patient selection and exclusion criteria were as detailed in Table 1 . All operations were performed under general anesthesia by the same surgeon with microscope-assisted transmeatal approach.



Table 1

Study inclusion and exclusion criteria.



























Inclusion criteria Exclusion criteria
Central perforations, Patients with septum deviation,
Perforations limited to one or two quadrants of the TM, Marginal perforation,
Manubrium mallei was not exposed, Atrophied TM or retraction pocket
TMP margins without inversion or atrophy All edges of the perforation are not seen under microscope
Healthy middle ear mucosa and dry ears
ABG was lower than 30 dB,
No clinical or radiological sign of cholesteatoma



Surgical technique


Following local Adrenaline and Lidocaine infiltration to tragal cartilage and four quadrants of the ear canal, cartilage with both-sided perichondrium was harvested from the tragus. Squamous epithelium was removed from the margins of the TMP with a circular knife or pick. The patients were divided randomly and consecutively into two groups: OC group (n = 12) had perforation dimensions and shape measured using the OC ( Fig. 1 ) and the control group (n = 13) had perforation measured with Fisch elevator. Gelfoam soaked with Adrenalin was left in the ear canal. A tragal perichondrium-cartilage graft was shaped after removing of the perichondrium at the medial part of the graft. The graft was shaped with a #11 blade with 0.5 mm longer than the diameters of the perforation. Graft was cut into shape of butterfly wings by cleaving the cartilage rim parallel to two layers of perichondrium with a razor blade ( Fig. 2 ). The graft was then through the canal, in such a way that circular groove of the graft grasps the anterior edge of perforation initially and then inserted with one wing of butterfly above and one below of the posterior margins of the perforation. Graft was poked medially with a pick and sucked with an aspirator to ensure satisfactory fitting. Tragal incision was sutured and trans-tragal suture was placed for preventing any possible hematoma on harvesting site. Patients were discharged on first postoperative day and prescribed with antibiotic (Sipro solution drop 0.3% Ciprofloxacin, Bilim, Turkey) and steroid (Onadron solution drop, dexamethasone, IE Ulagay, Turkey) ear drops as well as systemic oral Cephalosporin antibiotics. Patients were examined initially on first week and 2 months and 6 months after surgery.




Fig. 1


Otologic Compass measuring the size of the graft. (A) Supero-inferior diameter of the cartilage is measured to the nearest millimeters. (B) Antero-posterior diameter of the cartilage is measured to the nearest millimeters. (C) Cartilage graft is meticulously shaped under the microscope accordingly.



Fig. 2


Per-operative installation (diagram showing sagittal section of the composite graft). *perichondrium, **tragal cartilage.



Peroperative and postoperative evaluations


Duration of the surgery was measured to the nearest minute as the time passed between perforation measurement and satisfactory graft placement. Number of trials for satisfactory fitting of the cartilage graft was also noted. At sixth postoperative month; surgical success rates were evaluated via microscope in a blinded manner. Pure tone audiometry was also carried out at the sixth postoperative month visit in a blinded manner. The average on three frequencies (500, 1000 and 2000 Hz) of hearing thresholds in air and bone conduction and the Air Bone Gap (ABG) have been calculated. Improvements in ABG were calculated and compared. Results were statistically analyzed using the nonparametric Mann Whitney U test for comparison of means and categorical data was analyzed with non-parametric Fisher’s exacttest. P values smaller than 0.05 were accepted as statistically significant.

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Aug 24, 2017 | Posted by in OTOLARYNGOLOGY | Comments Off on A randomized prospective trial of a novel device for measuring perforation size during inlay ‘butterfly’ myringoplasty

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