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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 24  |  Issue : 1  |  Page : 38-41

Comparative retrospective evaluation of outcomes of tympanoplasty according to graft support materials


1 Sisli Hamidiye Etfal Training and Research Hospital, Otorhinolaryngology Head and Neck Surgery Department, İstanbul, Turkey
2 İzmir Katip Çelebi University Atatürk Training and Research Hospital, Otorhinolaryngology Head and Neck Surgery Department, İzmir, Turkey
3 Private Practice Clinic, Otorhinolaryngology Department, İzmir, Turkey

Date of Web Publication24-May-2018

Correspondence Address:
Dr. Bilge Türk
ENT Clinic, Sisli Hamidiye Etfal Training and Research Hospital, Sisli, Istanbul
Turkey
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/indianjotol.INDIANJOTOL_12_18

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  Abstract 


Objective: The aim of this study is to evaluate and compare the surgical outcomes and hearing results in tympanoplasty surgeries according to graft support material. The results of patients with hyaluronate-carboxymethylcellulose membrane and spongostan and the results of patients with only spongostan were compared. Materials and Methods: This was a retrospective comparative study of 118 tympanoplasty operations of 118 patients who underwent tympanoplasty in the Department of Otorhinolaryngology at a tertiary medical center from September 2000 to December 2005. The subjects were classified into two groups; Group 1 (n = 38) in whom both sodium hyaluronate-carboxymethylcellulose membrane and spongostan had been applied and Group 2 (n = 80) in whom only spongostan had been applied as graft support material. The rate of graft success and pure tone audiometric results were evaluated and compared between the groups. Chi-square test and Mann–Whitney U-test were used for the analysis. Results: Pre- and post-operative audiometric results including air-bone gaps were not significantly different between the groups. In all groups, the postoperative air-bone gap was significantly improved compared to the preoperative air-bone gap. Graft success rate in Group 1 and Group 2 were 89% and 71%, respectively. The rate of tympanic membrane perforation closure was significantly higher in Group 1 (P < 0.05). Conclusion: Depending on these results, we suggest sodium hyaluronate-carboxymethylcellulose membrane as an additional option as graft support material in tympanoplasties. The positive effect on graft success rate is documented in the present study. Further investigations are needed to evaluate the benefits and clinical outcomes of hyaluronate carboxymethylcellulose membrane.

Keywords: Biomaterials, hyaluronic acid, tympanoplasty


How to cite this article:
Türk B, Arslanoğlu S, Uğuz MZ. Comparative retrospective evaluation of outcomes of tympanoplasty according to graft support materials. Indian J Otol 2018;24:38-41

How to cite this URL:
Türk B, Arslanoğlu S, Uğuz MZ. Comparative retrospective evaluation of outcomes of tympanoplasty according to graft support materials. Indian J Otol [serial online] 2018 [cited 2019 Nov 13];24:38-41. Available from: http://www.indianjotol.org/text.asp?2018/24/1/38/233122




  Introduction Top


In otologic surgeries, the middle ear packing agent should provide temporary support for tympanoplasty repair until adequate healing and fibrous union can take place by means of maintaining the stability of the tympanic membrane graft and ossicular chain. When healing is completed, such packing should dissolve, providing optimal middle ear aeration, and leaving the repaired tissues free from unwanted connective tissue adhesions.[1]

Eradicating the existing pathology, creating a sound-conducting mechanism in a well aerated and mucosa lined middle ear cleft are the main goals of a successful tympanoplasty. Postoperative adhesions badly affect the surgical outcome.[2],[3]

In the present study, we investigated the effect of sodium hyaluronate carboxymethylcellulose (HA-CMC) membrane and spongostan versus only spongostan in the success of tympanoplasty surgery. Postoperative graft success rate and air-bone gap gain of the patients who underwent tympanoplasty were evaluated, and the results between the HA-CMC membrane and spongostan placed group, and only spongostan placed group were compared.


  Materials and Methods Top


Data of 118 patients (43 males and 75 females) ranging in age from 13 to 73 years old (mean 35) who had undergone tympanoplasty operations between January 2000 and December 2005 at a Otorhinolaryngology and Head and Neck Surgery Department of a tertiary care hospital were evaluated retrospectively. The trial was designed as a retrospective comparative study. Age, gender, type of operation, pre-post otoscopic findings, pre-post air-bone gaps of the patients were collected from the clinical achieve and assistant thesis data. The patients with revision ear surgery, the patients who had been operated on ear surgery for malignancy and the patients with no pre- and post-operative otoscopic examination findings and operation data, pre- and post-operative pure tone audiogram test data were excluded from the study. The study protocol and use of data were reviewed and approved by the institutional otorhinolaryngology head and neck surgery clinic chairman. All aspects of the study were conducted according to the Declaration of Helsinki.

Pure tone audiogram from 250 Hz to 8 kHz through Interacoustic AC-30 (Interacoustics A/S, 5500 Middlefart, Denmark) that had been performed to all of the patients were assessed from the data of the patients and were conformed to the specification in ISO 8253 (Acoustics Audiometric test methods; basic pure tone and bone conduction audiometry, Geneva, Switzerland). Hearing outcomes were evaluated considering the criteria stated by the Committee on Hearing and Equilibrium Guidelines, 1995.[4] Pre- and post-operative air-bone gaps were compared between the groups.

Surgical operation notes were evaluated, and data were collected. Underlay and over underlay tympanoplasty techniques had been utilized in the surgeries. Mastoidectomies had been whether performed or not, based on the pre- and intra-operative findings and depending on the surgical indications. Harvesting the temporalis muscle fascia or the conchal cartilage as graft material had been used in all of the tympanoplasty procedures. All of the tympanoplasties had been carried out by the staff surgeon or by the senior resident under supervision of the staff surgeon. The position of the graft had been controlled and corrected if necessary in each operation.

After the pathologies in middle ear and mastoid had been cleaned, harvested grafts had been placed. The patients were divided into two groups according to the material used for graft support. Spongostan had been placed to the middle ear cavity medial to the grafts in all of the patients. Thirty-eight patients in whom HA-CMC membrane (Seprafilm, Genzyme Inc., Cambridge, MA, USA), prepared convenient to cover the tympanic membrane perforation and graft size, had been placed medial and lateral to the grafts, as monolayer each before and after placing the grafts were taken as Group 1. Medial and lateral to the HA-CMC membrane also spongostan had been placed. Eighty patients in whom only spongostan had been placed medial and lateral to the placed grafts as graft support material were taken as Group 2.

A successful tympanoplasty was defined as the full take of the graft. Furthermore, reducing the air-bone gap to <20 dB was also determined as successful hearing results.

Graft success rates, pre- and post-operative pure tone audiogram air-bone gaps were compared between the groups.

Statistical analysis

During the statistical evaluation of data, quantitative variables were interpreted with Mann–Whitney U-test, while categorical variables with Chi-square test. All analysis was performed by using SPSS for Windows statistical package with 95% sensitivity and P < 0.05 was accepted as statistically significant.


  Results Top


Data from 118 tympanoplasty surgeries were evaluated. The patients were divided into two groups according to the materials used for graft support. Spongostan had been placed to the middle ear cavity medial to the grafts in all of the patients. Patients in whom HA-CMC membrane and spongostan had been used as graft support material were included in Group 1 consisting of 38 (14 males, 24 females; with an age range of 13–64 years old, mean 36) patients. Patients in whom only spongostan had been used were included in Group 2 consisting of 80 (29 males, 51 females; with an age range of 15–73 years old, mean 35) patients [Table 1]. Pre- and post-operative clinical otological examination findings of all patients were evaluated. The mean time interval between pre- and post-operative period was 18.6 months, minimum period being 3 months and maximum period being 50 months postoperatively.
Table 1: Age and sex distribution of the patients

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Surgical procedure

Tympanoplasty without mastoidectomy had been carried out in 26 (22.0%) ears, tympanoplasty with atticotomy in 42 (35.5%) ears, intact canal wall mastoidectomy in 34 (29.0%) ears and canal wall down mastoidectomy in 16 (13.5%) ears.

Harvesting the temporal muscle fascia as a graft material had been used in 114 (96.6%) surgeries and conchal cartilage graft in 4 (3.4%) surgeries. In Group 1, temporal muscle fascia graft had been used in 32 (94.1%) and conchal cartilage graft had been used in 2 (5.9%) patients whereas temporal muscle fascia graft had been used in 78 (97.5%) patients and conchal cartilage graft had been used in 2 (2.5%) patients in Group 2.

Graft success rates

While the graft success rate in the Group 1 was 89.5%, it was 71.3% in the Group 2 postoperatively and this difference was statistically significant (P = 0.028) [Table 2].
Table 2: Graft take rates of Group 1 and Group 2

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Hearing outcomes

Pre- and post-operative pure tone audiogram of the patients was compared and postoperative air-bone gap ≤20 dB was accepted as serviceable successful hearing outcome. As shown in [Table 3] and [Table 4], serviceable hearing (air-bone gap ≤20 dB) was achieved in 52.6% of Group 1 (n = 38), and in 57.5% of Group 2 (n = 80) postoperatively. In all groups, the postoperative air-bone gap was significantly improved compared to the preoperative air-bone gap, but pre- and post-operative audiometric results including air-bone gaps were not significantly different between the groups (P = 0.310) [Table 5]. The mean preoperative air conduction threshold was 49 dB, mean postoperative air conduction threshold was 38 dB and the mean improvement was 10.6 in Group 1. Furthermore, in Group 2 while mean preoperative air conduction threshold was 42 dB, mean postoperative air conduction was 33.5 dB, the mean improvement being 8.5 dB.
Table 3: Air-bone gap changes of the Group 1 pre- and post-operatively

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Table 4: Air-bone gap changes of Group 2 pre- and post-operatively

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Table 5: Air-bone gap changes of the Group 1 and Group 2 postoperatively

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  Discussion Top


Tympanoplasty is one of the commonly performed procedures in the fields of otology. To create a sound-conducting mechanism in a well-aerated, mucosal lined middle ear cleft is the goal of a successful tympanoplasty.[2] Adhesions in human middle ear with chronic infection are well known to the ear surgeon. By causing ossicular or implant fixation and to act as barriers to aeration in mastoid cavities, fibrous bridges in the middle ear after tympanoplasty are believed to act to reduce hearing.[5] These facts make it necessary to look for materials against the development of adhesions. In this respect, one possibility is hyaluronic acid or hyaluronan.[6],[7] Hyaluronic acid also is involved in modulating inflammatory airway processes and mucociliary clearance.[8] Hyaluronic acid or hyaluronan treatment also seems to be an alternative to myringoplasty when treating small- and medium-sized dry perforations.[4],[9],[10],[11],[12]

Hyaluronic acid, a glycosaminoglycan, is a naturally occurring extracellular polysaccharide possessing unique anti-inflammatory and viscoelastic properties.[1],[4] Seprafilm ® (Genzyme Co., Cambridge, MA, USA) is a bioabsorbable membrane composed of sodium hyaluronate and carboxymethylcellulose.[13] Seprafilm® is most commonly used to reduce postoperative adhesions effectively.[14] This membrane had been shown to serve as a barrier to fibrotic healing, which may enhance the vascular delay and facilitate reoperation.[15] Within 24 h of application, HA-CMC membrane turns to gel while remaining in place to separate adhesiogenic tissues during the 1st few days when adhesions are likely to develop, and it is cleared from the body within 28 days.[16] HA-CMC membrane had been shown to reduce postoperative adhesion formation as well as regeneration.

Today, gelatin products such as Gelfoam and absorbable hemostatic products like spongostan are commonly used in otosurgery, particularly as a scaffolding substance to support the tympanic membrane grafts and ossicular chain and as a closing material of the oval window.[5],[6]

With the barrier technique traumatized surfaces are kept covered during regeneration, thus preventing adherence and reducing adhesion formation. The aim of this study was to evaluate the effect of HA-CMC membrane and spongostan versus only spongostan as graft support material in tympanoplasty surgeries.

In a study, the use of adhesion barrier HA-CMC membrane in mastoidectomy surgeries had resulted in the preservation of the aeration of the mastoid cavity and also had prevented retraction of postauricular skin. They had inserted the membrane into the mastoidectomy defect in whom intraoperatively a second-stage surgery has planned on. All patients had been reoperated, and mastoid cavities had been reevalauted.[17] In the present study, the HA-CMC membrane had been placed lateral and medial as monolayer on each side of the tympanic membrane graft to prevent adherence and to reduce adhesion formation in Group 1.

Hyaluronic acid is a naturally occurring extracellular polysaccharide possessing unique anti-inflammatory and viscoelastic properties. The efficacy of hyaluronic acid foam in the prevention of middle ear adhesions and other structural abnormalities in guinea pigs undergoing experimental tympanoplasty was investigated, and hyaluronic acid foam appears to be a promising middle ear packing agent.[1] Furthermore, hyaluronan was reported to improve the restoration of the fibrous connective tissue layer. Improvement of the healing pattern of experimental tympanic membrane perforations by topically applied hyaluronan preparations in the rat was elucidated.[10] Use of HA-CMC membrane in the repair of the subtotal tympanic membrane perforations in an experimental rat models showed that perforations healed more readily.[13] A study had been conducted that evaluated the hyaluronic acid fat graft myringoplasty (HAFGM) technique for tympanic membrane perforation repair in a pediatric population. They found that the success rate of HAFGM is superior to fat graft myringoplasty.[12]

In terms of graft success rate in the present study, the rate of tympanic membrane perforation closure was significantly higher in Group 1. This can be related to the effect of hyaluronic acid on the regulation of the healing pattern of fibrous layer and prevention of dehydration of the perforation margins. HA-CMC membrane had been placed just medial and lateral to the grafts. Thus, HA-CMC membrane appears to be a promising graft support material, especially in graft takes.

When reporting the results of tympanoplasty, the postoperative air-bone gap closure and graft success rate are commonly reported as indicators of surgical outcome. In the present study, there was no significant difference in the air-bone gap closure results between only spongostan used and the HA-CMC membrane and spongostan used group. In both groups, the postoperative air-bone gap was significantly improved compared to the preoperative air-bone gap. Air-bone gap closure within 20 dB was achieved in 52.6% of the Group 1 (both spongostan and HA-CMC membrane used) patients and in 57.5% of the Group 2 (only spongostan used) patients.

Our study has several biases, some inherent to the retrospective nature of the data collection. Our sample size of Group 1 is 38; due to lack of data of postoperative pure tone audiogram tests and otoscopic findings, some of the patients are excluded from the study. Patients were not randomized, and most of the patients were historical patients included between 2000 and 2005. After, the thesis study had ended no more HA-CMC membrane had been placed as graft support material. Hence, only the records from the study period were evaluated. Larger sample sizes would give more information and prospective studies with longer follow-up time should give additional information.


  Conclusion Top


Based on these findings, we suggest sodium hyaluronate-carboxymethylcellulose membrane as an additional option as graft support material in tympanoplasties. The positive effect on graft success rate is documented in the present study. Further studies with larger cohorts are needed to evaluate the benefits and clinical outcomes of hyaluronate carboxymethylcellulose membrane.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Krupala JL, Gianoli GJ, Smith RA. The efficacy of hyaluronic acid foam as a middle ear packing agent in experimental tympanoplasty. Am J Otol 1998;19:546-50.  Back to cited text no. 1
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Bagger-Sjöbach D, Holmquist J, Mendel L, Mercke U. Hyaluronic acid in middle ear surgery Am J Otol 1993;14:501-6.  Back to cited text no. 6
    
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Torretta S, Marchisio P, Rinaldi V, Carioli D, Nazzari E, Pignataro L, et al. Endoscopic and clinical benefits of hyaluronic acid in children with chronic adenoiditis and middle ear disease. Eur Arch Otorhinolaryngol 2017;274:1423-9.  Back to cited text no. 8
    
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Stenfors LE. Treatment of tympanic membrane perforations with hyaluronan in an open pilot study of unselected patients. Acta Otolaryngol Suppl 1987;442:81-7.  Back to cited text no. 9
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Laurent C, Hellström S, Fellenius E. Hyaluronan improves the healing of experimental tympanic membrane perforations. A comparison of preparations with different rheologic properties. Arch Otolaryngol Head Neck Surg 1988;114:1435-41.  Back to cited text no. 10
    
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Briggs RJ, Luxford WM. Chronic ear surgery: A historical review. Am J Otol 1994;15:558-67.  Back to cited text no. 11
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Saliba I, Knapik M, Froehlich P, Abela A. Advantages of hyaluronic acid fat graft myringoplasty over fat graft myringoplasty. Arch Otolaryngol Head Neck Surg 2012;138:950-5.  Back to cited text no. 12
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13.
Konakçi E, Koyuncu M, Unal R, Tekat A, Uyar M. Repair of subtotal tympanic membrane perforations with seprafilm. J Laryngol Otol 2004;118:862-5.  Back to cited text no. 13
    
14.
Kawamura H, Yokota R, Yokota K, Watarai H, Tsunoda Y, Yamagami H, et al. A sodium hyaluronate carboxymethylcellulose bioresorbable membrane prevents postoperative small-bowel adhesive obstruction after distal gastrectomy. Surg Today 2010;40:223-7.  Back to cited text no. 14
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Caylan R, Bektas D. Preservation of the mastoid aeration and prevention of mastoid dimpling in chronic otitis media with cholesteatoma surgery using hyaluronate-based bioresorbable membrane (Seprafilm). Eur Arch Otorhinolaryngol 2007;264:377-80.  Back to cited text no. 17
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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