Journal of Otology & RhinologyISSN: 2324-8785

All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.
bahis siteleri bahis siteleri bahis siteleri casino siteleri

Research Article, J Otol Rhinol Vol: 5 Issue: 5

Audiological Outcomes of Type 1 Tympanoplasty done with Fibrin Glue

Mohanty S* and Kurian AT
Department of ENT, Head and Neck Surgery, Sri Ramachandra University and Hospital, Tamil Nadu, India
Corresponding author : Mohanty S, Professor, HOD
Department of ENT, Head & Neck Surgery, Sri Ramachandra University & Hospital, Porur, Chennai – 600125, Tamil Nadu, India
Tel: +91 9840131091
E-mail: [email protected]
Received: June 13, 2016 Accepted: July 11, 2016 Published: July 18, 2016
Citation: Mohanty S, Kurian AT (2016) Audiological Outcomes of Type 1Tympanoplasty done with Fibrin Glue. J Otol Rhinol 5:5. doi:10.4172/2324-8785.1000291

Abstract

Introduction: The aim of this study was to assess the audiological outcomes of type 1tympanoplasty done with fibrin glue by comparing the pre and post-operative pure tone average.

Materials and Methods: Thirty three patients who were diagnosed to have chronic otitis media mucosal type and underwent type 1tympanoplasty with fibrin glue in the department of ENT of a tertiary care hospital between August 2014 and September 2015 were followed up for six months. Pre and post-operative pure tone averages were noted. Post operatively pure tone averages were noted at the third and sixth month follow-up.

Results: A total of thirty three patients underwent the procedure. The pre op mean pure tone average was 34.45dB which improved to 24.55dB three months after the surgery and to 21.73dB six months after the surgery. Pre operatively 66.7% of the patients had a hearing loss of more than 31dB and only 3% had a hearing loss of less than 20dB, where as post operatively only 15.1% had a loss of more than 31dB and 48.5% had a loss of less than 20dB. One case of graft displacement was seen.

Conclusion: The learning curve in using fibrin glue in tympanoplasty is not very steep and can be easily mastered. Through our study we have observed that using fibrin glue provides good hearing outcomes post-operatively and can be used especially in patients with large perforations to assure good hearing outcomes with graft uptake rates comparable to conventional methods.

Keywords: Fibrin glue; Tisseel; Tympanoplasty; Puretone audiometry

Keywords

Fibrin glue; Tisseel; Tympanoplasty; Puretone audiometry

Introduction

The closure of a central perforation in the tympanic membrane through a type 1tympanoplasty with a post-aural incision is widely done. Surgeons based on their preference employ various techniques like underlay, overlay or inlay methods. Different materials were used to ensure the adherence of the graft with the remnant tympanic membrane. Ringenberg et al. [1] attempted to use fat in 1978, Camnitz et al. [2] used paper tape patching in 1985, Saito et al. [3] used micropore strip in 1990. Yuasa et al. [4] attempted to secure the graft using fibrin glue.
Fibrin glue in a form similar to its current composition was used first successfully by Matras et al. [5-8] to seal severed nerves first in animals and then in humans. Following this fibrin glue has found many uses in surgery. Fibrin glue is being used in cerebrospinal fluid leak repairs, to prevent leakages in colonic anastomosis, to achieve haemostasis in cases where conventional methods (sutures, ligatures and cautery) are either ineffective or impractical and to achieve haemostasis in heparinized patients [8-11]. The usage of fibrin glue is being explored for various otorhinolaryngology procedures, especially in otological surgeries like tympanoplasty.
In this study, we explore the use of fibrin glue (TISSEEL, Baxter) in type 1typanoplasty and assess the audiological outcomes by comparing the pre and post-operative pure tone averages.

Materials and Methods

Thirty three ears with tympanic perforation underwent type 1tympanoplasty with fibrin glue in the department of ENT at a tertiary care centre between August, 2014 and September, 2015. Informed consent was obtained from all the patients for participation in this study. They were followed up for six months after surgery and the pre and postoperative pure tone audiometry results of the 33 ears were analysed in this study. They were 8 male patients and 25 female patients with a mean age of 32.67 years (range: 24–49 years). Patients below 20 and above 50, patients with sensorineural hearing loss, revision cases, patients with chronic otitis media – active stage and patients with general systemic diseases were excluded from the study. Pure tone audiometry was done pre-operatively and post-operatively after 3 and 6 months. Indications for surgery were patients with COM-Mucosal type(inactive stage) between the age group of 20 – 50 years, with a preoperative pure tone average of less than 50dB.
Surgery: Tympanoplasty was done via a post aural William Wilde incision. Temporalis fascia graft was taken, posterior meatotomy was done, tympanomeatal flap was elevated and the graft was placed medial to the handle of malleus after freshening the edges of the perforation. After the tympanomeatal flap was repositioned fibrin glue(TISSEEL, Baxter) was applied along the edges of the perforation.
Follow-up: The patients were followed to assess the hearing (pure tone audiometry). Follow up was done after one week, one month, three months and six months. PTA was done on the third and sixth month.
Statistical Analysis: Mean and standard deviation were estimated for the sample. Student ‘t’ test and chi-square test was applied to find the level of significance between the pre and post-operative pure tone averages. SPSS (version 19) and Microsoft Excel (2013) software were used.

Results

Age distribution
The ages of the patients ranged from 22 to 49 with a mean age of 32.67 (Figure 1).
Figure 1: Age Distribution.
Gender and side distribution
33 patients were included in the study. 25 of these patients were female and 8 were male (Figure 2). 23 left ears and 15 right ears were operated (Figure 3).
Figure 2: Gender and Side Distribution 25 of these patients were female and 8 were male.
Figure 3: Gender and Side Distribution 23 left ears and 15 right ears.
Hearing assessment
All the patients followed up for a period of six months to assess hearing. The patients underwent pure tone audiometry and the average of the hearing thresholds at 500, 1000, 2000 and 3000 hz was taken as the pure tone average. The pre-operative mean pure tone average was 34.35 dB (Figure 4) with 66.7% of the patients having a value of more than 31 dB, 30.3% had a value of 21-30 dB and 3% had a value of 11-20 dB (Table 1). At the sixth month post-operatively the mean pure tone average was 24.33 dB (Figure 4) with 15.1% of the patients having a value of more than 31dB, 36.4% had a value of 21- 30dB and 48.5% had a value of 11-20dB (Table 2). Graft was in-situ at the sixth month follow-up for 32 patients and graft displacement has seen in one patient.
Figure 4: Pre-operative mean pure tone average.
Table 1: Pre-Operative ABG.
Table 2: Post-Operative ABG.

Discussion

Type 1tympanoplasty is an old procedure and various methods and materials have been used to improve the graft uptake and hearing of the patient. Improvement in hearing is very essential, as it is the primary complaint of most of the patients with chronic otitis media (mucosal).
The study by Maeta et al. [12] done in Japan shown that fibrin glue, provided a better hearing outcome than conventional methods. Tidrick et al. [13] and Cronkite et al. [11] used blood plasma and fibrinogen, which were clotted with Thrombin and they reported relatively high failure rates due to poor adhesive strength and durability of the seal formed. With the development of the twocomponent fibrin sealant, it has found many uses in surgery.
Yuasa et al. [4-6] used fibrin glue for type 1tympanoplasty in 1989 successfully and obtained comparable outcomes with regard to hearing and graft uptake with conventional methods. In 1998, Maeta et al. [12] published their study comparing tympanoplasty done by orthodox methods to those done with fibrin glue. They observed that though orthodox methods had better graft uptake, their method of tympanoplasty with fibrin glue showed improved hearing outcomes especially in patients with large perforations.
The aim of this study was to look further into the hearing improvement in type 1tympanoplasty done with fibrin glue. We have recorded the pure tone average of all the patients’ pre and post operatively. The pre-operative mean pure tone average value was 34.35dB. We have noted a statistically significant improvement (p value=0.0001) in the pure tone average post-operatively when recorded at the third month and a further improvement though minimal was noted in the pure tone average at the sixth month (24.33dB) in most cases. In some cases the pure tone average worsened at the sixth month when compared to the third month, this could be associated with the subjective nature of the pure tone audiometry test as there were no obvious signs noted on examining the ears of these patients.
Pre operatively 66.7% of the patients presented with a pure tone average of more than 31dB which reduced to 15.1% six months post operatively. The pure tone average of 3% of the patients pre operatively was less the 20dB and post operatively 48.5% of the patients fell in this group. Of the 33 patients only 1 patient presented with graft displacement at the end of the six month follow up.

Conclusion

The use of fibrin glue in Tympanoplasty studied rarely. Literature shows that there are definite audiological benefits on using fibrin glue in type 1tympanoplasty.
The learning curve in using fibrin glue in tympanoplasty is not very steep and mastered easily.
Through in our study we have observed that using fibrin glue provides good hearing outcomes post-operatively and used especially in patients with large perforations to assure good hearing outcomes with graft uptake rates comparable to conventional methods. However, the cost implications notwithstanding it are a good biomaterial for use in middle ear reconstructive surgeries.

References














Track Your Manuscript

Media Partners

Associations