Thursday 15 August 2013

TRANSTYMPANIC LOW DOSE GENTAMICIN IN MENIER’S DISEASE.

TRANSTYMPANIC LOW DOSE GENTAMICIN IN  MENIER’S DISEASE.


K.K.DESARDA.  D. BHISEGAONKAR   SHEETAL SANT   KEM HOSPITAL PUNE.


ABSTRACT:

Current role of transtympanic gentamicin therapy in the management of unilateral meniere’s disease is discussed in detail with its efficacy in  the management.
Transtympanic low dose gentamicin infusion is an alternative to surgical labyrinthectomy and Vestibular nerve section for the treatment of refractory vertigo associated with Meniere’s Gentamicin, the current drug of choice provides excellent vertigo control and is a less Invasive method to destroy the vestibular labyrinth. The goal of the treatment is to eliminate the abnormal vestibular inputs from the vestibular inputs from the diseased ear without adversely affecting the hearing. It’s salutary effect results from the damage of both the sensory neuroepithelium and the dark cells of the labyrinth. Intratympanic low dose gentamicin may cause sensory neural hearing loss hearing loss in some patients {10–15%}. Despite this S.N.. loss, results are encouraging. 50 cases of unilateral Meniere’s disease were treated at KEM hospital, Pune, during 1996 to 2012 with the follow–up of 2 to 4 yrs. All cases were infused with low dose gentamicin transtympanically for 4 to 6 weeks. This prospective study of gentamicin infusion revealed high success rate of controlling vertigo in about 92% patients. This treatment modality offers a less invasive but effective option for treating refractory vertigo of Meniere’s disease.We strongly recommend this modality of treatment for treating Mniere’s disease.

Low dose -- our preference
The low dose method involves using 1-2 injections of gentamicin, waiting a month between injections. This variant stops vertigo 70-80% of the time, with no significant side effects at all. The low dose variant is relatively new, and there is not nearly as much data concerning outcome as the high-dose variant.
The 2nd injection is given only if there has been a vertigo spell in the 2 weeks prior. In other words, instead of titrating to the onset of damage to vestibular system (as is done for high-dose ITG/TTG), the criterion is a good effect on the disease. This simple idea seems to result in far better results. Occasionally a 3rd dose is given. Usually this results in complete vestibular loss



Key words: Gentamicin, Meniere’s, chemical labyrinthectomy, micro wick

Introduction
Meniere’s disease is a clinical disorder characterized by acute episodes of vertigo, fluctuating hearing loss, aural fullness & tinnitus2. 80% patients of Meniere’s disease are treated successfully by medical treatment. Remaining 20% who have failed medical treatment need either surgical or chemical ablation of vestibular function. Surgical procedures designed to prevent endolymphatic hydrops such as cochleostomy, endolymphatic sac shunt are falling out of favour due to high incidence of sensorineural hearing loss (20–30%). Vestibular nerve section, although very effective is a difficult surgery with significant morbidity and not uncommon complications

Schucknecht (1957) introduced transtympanic mode of delivery with streptomycin4 & Beck Schmidt (1978) first used gentamicin by the Transtympamnic route5 for treating Meniere’s disease and proved the efficacy of the gentamycin infusion. The success rate was 92–100%2,4,5,6. This prospective study of 50 patients of unilateral Meniere’s disease in KEM hospital, Pune, during 1996–2012 revealed that intratympanic gentamicin therapy has a success rate of controlling vertigo in 92% with S. N. loss in 10% of the cases. This being a safe, less invasive and readily accepted treatment modality was the choice of treatment in controlling refractory vertigo of Meniere’s disease. The intratympanic low dose gentamicin infusion (40mg/ml) buffered with 7.5% sodium bicarbonate solution was used slowly over a 10 minutes period. We have recorded our observations and post infusion results for over sixteen years and found that gentamicin therapy is an ideal option to surgical labyrinthectomy. The ease with which gentamicin can be obtained and apparently lower incidence of its cochleotoxic side–effect has currently made it the preferred aminoglycoside for chemical treatment of Meniere’s disease.

Materials & methods:
(TABLE I, II, III)
50cases of 32 males & 18 females within age group of 30–70 years of proved unilateral Meniere’s disease were treated with repeated transtympanic gentamicin infusion through the grommet for 4–6 weeks on weekly basis. During the study, we have excluded CSOM., acoustic neuroma, acoustic trauma, barotraumas, diabetes, hypertension, cervical spondylosis & anaemia with the relevant investigations. Only unilateral Meniere’s disease cases were included in the study group. Prior to infusion, all patients were subjected to routine investigation such as PT Audiometry, Tone decay, SISI, caloric tests, MRI. brain especially for internal auditory meatus and posterior cranial fossa and all relevant biochemical tests. All 50 cases were given medical treatment for at least 3 months prior to gentamicin infusion therapy. The treatment includes diuretics, vasodilators, labyrinthine sedatives, antiallergics and steroids.

All cases were also informed about the side effects of this treatment such as sensorineural hearing loss in 10%, ataxia lasting for 4–6 weeks and imbalance until central compensatory mechanisms take over and the need for the head and neck Catwhorne Cooksey’s exercises after the treatment end–point. The infusion of low dose gentamicin 40 mg/ml was used with dilution with 7.5% sodium bicarbonate solution. 10mg/ml gentamicin was slowly infused intratympanically by poster inferior quadrant myringotomy through grommet .

The study ear was elevated by 45 degrees and infusion continued slowly over 10 minutes. The patient maintained the supine position with the study ear above for about 45 minutes post–infusion in the recovery room. The infusions were administered on weekly basis for 4–6 wks. Depending on clinical response in controlling vertigo. The end point of the treatment was total relief from vertigo and associated symptoms. The morbidity of unsteadiness/dysequilibrium, S.N. loss and the appearance of spontaneous nystagmus were cardinal signs of the efficacy of the gentamicin infusion.

Table I: Age distribution:
Age group (years) No. of cases
30–40
41–50
51–60
61–70
Total 06
13
22
09
50


Table II – The sex ratio:
Sex No. of cases
Male
Female
Total 32
18
50

Table III – Transtympanic infusions required:
No. of Infusions Cases
1–2
3–4
5–6
Total 10
23
17
50

The results (As per guidelines of AAO–HNS, 1985) 7:
Table IV: Vertigo Relief (n=50)
Vertigo control No. of patients Percentage
Complete 36 72
Substantial 10 20
Limited 02 04
Insignificant 02 04
Worse 00 00

Table V: Hearing loss (n=50)
Hearing loss No. of patients Percentage
Worsened 05 10
Unchanged 37 74
Improved 08 16


Table VI : Tinnitus control (n=50)
Tinnitus control No. of patients Percentage
Absent 09 18
Improved 36 72
Unchanged 05 10

Table VII: Aural Fullness Control (n=50)
Aural Fullness Control No. of patients Percentage
Absent 31 62
Improved 19 38
Unchanged 00 00


Table VIII : Post Treatment  Caloric Response

Post Treatment Caloric Response          No. of patients Percentage
No. response                36         72
Poor response                10         20
No. Change                04         08

Table IX: Comparison of Results of various Authors.

          Authors        Vertigo Control       Hearing Loss
Beck & Schmidt (1978)5                95%              15%
Odkivist (1988) 8                95%              22%
Nedzelski (1993) 9               100%              37%
Lorne (1993) 10               100%              41%
Susanne & Pyykko (1995) 11                90%              32%
KEM Hospital Pune, Study (KKD)                92%              15%

It was observed that 4–6 wks period was taken to achieve excellent vertigo control. Post infusion audio vestibular tests were done in all cases to record the observations and results.


Results: (Table–IV, V, VI, VII, VIII)

During study, we have recorded complete control in 36 cases (72%), limited in 2 cases (4%) and insignificant in 2 cases (4%). The hearing loss worsened in 5 cases (10%), improved in 37 cases (74%) & not improved in 6 cases (18%). The tinnitus was absent in 9 cases (18%), improved in 36 cases (72%), and unchanged in 5 cases (10%). The aural fullness was absent in 31 cases (62%), improved in 19 cases (38%) and unchanged in 0 cases (0%).

Discussion: (Table IX)

One of the exciting new developments in inner ear research is the feasibility to place medications directly into the inner ear. Transtympanic low dose gentamicin infusion can be done by several methods such as transtympanic injection13, Micro Wick of Silverstien1, Microcatheter4, myringotomy & grommet, etc. the gentamicin is the current amino glycoside of choice because it is less cochleotoxic than streptomycin3 (John Shea, 1994) 13. Gentamicin has its ototoxic effect on the sensory neuroepithelium and it destroys the endolymph secreting cells (dark cells of utricle, base of ampullae & lateral wall of crus communes) 14.

We have chosen the myringotomy & grommet route for its simplicity and the repeated procedures required during the treatment. Since this is an office procedure, can be repeated on weekly basis, easily accepted by all the patients and is noninvasive and cost effective, this mode of drug delivery appeared to be the best to us.

Review of the literature revealed that results obtained in vertigo control and hearing loss are variable. Beck & Schmidt (1978) 5, had vertigo control was 95% and S. N. hearing loss was 15%. Odkivist (1988)8, had 95% vertigo control and 22% S. N. loss, Nedzelski (1992)9, had 100% vertigo control and 37% S.N. loss. Lorne (1993) 10 also had 100% vertigo control and 47% S. N.Loss. Susanne and Pyykko (1995)11 showed 90% vertigo control and 32% S.N. loss. Our study revealed 92% vertigo control and 15% S.N.loss.

From the study it appears that there are some disadvantages for gentamicin therapy such as 10% risk of hearing loss. Tinnitus and aural fullness may persist, and it is also difficult to regulate the actual degree of diffusion into perilymph bypassing the cohlea. It was also noted that there are various factors altering absorption of gentamicin in the inner ear like the thickness of round window membrane, scarring and adhesions in middle ear, head position and dependency or round window, potency of eustatian tube, rate of turnover of perilymph and endolymph and individual susceptibility to ototoxic gentamicin3.

The concentration of intratympanic gentamicin is most important in predicting the degree of ototoxicity while the duration of therapy appears to be less significant15. The optimal treatment regimen for Meniere’s disease will be such that vestibular hypo activity will be achieved but there will be no hearing loss.

It was also observed during the study that the no response to gentamicin infusion is probably be due to be central lesion e.g. migraine, micro vascular compression or it may be a bilateral Meniere’s disease or it could be due to the round window adhesions (which prevents proper passage of the drug delivery  to the inner ear) or other causes of vertigo. Due respect must be given to the accurate diagnosis of the Meniere’s disease and until one is very very sure about the diagnosis, one should not try this treatment. The other modality of treatment is nonchemical ablation of the vestibular endorgan by ultrasonic and cryosurgery which is not easily available at all the centeres2.

In our study all cases were administered medical treatment for 3 months before the transtympanic infusion. The follow–up was kept on regular basis at 3 months, 6 months, and yearly after the completion of the treatment. It was our observation that six patients (12%) developed irritative nystagmus following transtympanic gentamicin perfusion during the treatment, which recovered in 2 weeks time. This unique new finding may represent a recovery phenomenon resulting from a temporarily reversible ototoxic effect in the treatment ear. Despite small percentage of S. N. loss (10%) the results are encouraging with gentamicin infusion treatment

.


Author’s Conclusion:

Interest has been growing in the intratympanic application of medicine for the control of Meniere disease and other otologic maladies. Although the use of the aminoglycosides streptomycin and gentamicin has received the most attention, other medications, including dexamethasone and lidocaine, have also been given transtympanically. Despite the growing amount of research, many questions remain un ansered regarding the efficacy, safety, and dosing regimens of these treatments.
Optimal methods of inner ear drug delivery will depend on toxicity, therapeutic dose range, and characteristics of the agent to be delivered. Advanced therapy development will likely require direct intracochlear delivery with detailed understanding of associated pharmacokinetics.
Transtympanic  low dose gentamicin infusion has a consistent vertigo control (92%), is relatively inexpensive, easy to perform under local anesthesia as an office procedure and without significant morbidity. This chemical ablation provides a reasonably safe and effective method for controlling acute, recurrent vertigo in patients of Meniere’s disease who have failed medical therapy.
Intratympanic therapies offer an advantage over endolymphatic sac or destructive surgeries in that injections can be repeated with minimal costs and morbidity, and may be titrated to clinical response.

We strongly recommend this modality of treatment for severe, unilateral, refractory intractable vertigo of Meniere’s disease before destructive surgery is contemplated because long–term success with this procedure is significantly greater than with sac surgery or vestibular neurectomy.

References
Silverstein H. (1999) : Use of a new device, the Micro Wick (tm) to deliver medication to the inner ear. ENT Journal 79:8.
Scott Brown’s Otolaryngology, 6th Edition (1997): Butterworth & Heinemann Publication, Meniere’s Disease, 3:19:1–3:19:38.
Otolaryngologica Clinics of North America, Hirsh B. E., Kamerer D. B. (Dec. 1997): Role of chemical labyrinthectomy in the treatment of Meniere’s disease, Vol. 30, No. 6, 1039–1049.
Schuknecht H. F. (Dec.1997) : Ablation therapy in the management of Meniere’s disease. Acta Otolaryngology supplement (Stockh), 13:1–41.
Beck C., Schmidt C. L., (1978) : Ten years of experience with intratympanically applied streptomycin (Gentamicin) in the therapy of morbus Meniere, Archives Otolaryngology 221:149–152.
Surgery of the ear, Shambaugh, Glasscock, 4th Edition. W. B. Sounder’s Publication, Surgical treatment of periferal vestibular disorders, 467–500.
Pearson B. W., Brackmann D. E. (Chairman) (1985): Committee on hearing and equilibrium guidelines for repeating treatment results in Meniere’s disease. Otolaryngology Head and Neck Surgery, 13:579–581.
Odkvist L. M. (1988): Middle ear ototoxic treatment for Meniere’s disease. ACT Otolaryngology (Stockh) supplement 457:83–86.
Nedzelski J. M., Bryle G. E., Pfleiderer A. G.(1993): Treatment of Meniere’s disease: Update of an ongoing study. American Journal of Otolaryngology 14:278–282.
Lorne S. Parnes, Duncan Riddel, (1993): Irritative spontaneous nystagmus following intratympanic gentamicin for Meniere’s disease, Laryngoscope 103:745–759.
Susanna K., Pyykko I., Ishizaki H. & Aalto H., (1995): Effect of intratympanically administeree gentamicin on hearing & tinnitus in Meniere’s disease. Acta Otolaryngology (Stockh) supplement, 520:184–185.
Hirsch B. E., Kamerer D. B. (1997): Intratympanic Gentamicin in Meniere’s disease. American Journal of otolaryngology, 18:44–51.
John Shea Jr. & Xianxi G. E. (April 1994): Streptomycin perfusion of the labyrinth through the round window plus intravenous streptomycin, Otolaryngologc clinics of North America 78:542–561.
Kimura R. S. (1979): Distribution structure & function of dark cells in vestibular labyrinth American journal of Otolaryngology 78:542–561.
Mangnuson M., Paloan S. (1991): Delayed onset of ototoxic effects of gentamicin in the treatment of Meniere’s effects of gentamicin in the treatment of Meniere’s disease, Acta otolaryngology (Stockh) 111:671.
Address for correspondence
Dr. K. K. Desarda
Benali, Karve Road, Nal Stop,
Pune 411 004, Maharashtra, India.

Contributed by Dr. K. K. Desarda

TRAGAL CARTILAGE IN MIDDLE EAR RECONSTRUCTION

          TRAGAL CARTILAGE IN MIDDLE EAR RECONSTRUCTION


Desarda K. K.a Dr. Nilima. Kharade,Dr.Sheetal (ENT Residents)
Professor and head department of ORL, KEM hospital, Pune.
Chief residents department of ORL, KEM hospital.
This paper was read at AOI conference, Cochin, January 2000.

Email: kdesarda@gmail.com
Address:
Dr.K.K.Desarda.MS.FACS.DLO.(Lond)
Prof.Emeritus & Head Otolaryngology,
KEM Hospital, Pune

Abstract

Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction

To date, temporalis fascia and perichondrium remain the most commonly employed materials for closure of tympanic membrane perforations.  The success rate in TM reconstruction with these materials approaches 90%. In certain situations, such as the atelectatic ear, cholesteatoma, and revision tympanoplasty, the results with these materials have not been as gratifying.  Fascia and perichondrium have been shown to undergo atrophy and subsequent failure in the postoperative period.  This has led to the use of cartilage, which is a less compliant, more rigid material that resists resorption and retraction.  It has also been shown by different studies that it is well tolerated by the middle ear and hearing results have been comparable with those of fascia and perichondrium

The study presents six hundred ear operations of varied middle ear pathology using tragal cartilage and perichondrium as a choice graft. The technical advantages of tragal perichondrium graft in myringoplasty, ossiculoplasty, ossiousplasty, and mastoid cavity obliteration are discussed.





KEM Hospital Pune.

The study was conducted at K.E.M. Hospital, ENT department during 1980 to 2000. we have recorded our observations and results and concluded that tragal perichondrium and cartilage is an ideal graft material for reconstructive tympanoplasty. The objective of study was to assess the efficacy of tragal perichondrium and cartilage, the functional capacity in restoring hearing acuity, it’s mechanical survival, it’s extrusion rate and it’s functional integrity in tympanomastoid reconstruction.

Keywords: Cartilage, Perichondrium, Sialastic.

Introduction




INTRODUCTION:


The technique of ‘Reconstructive Tympanoplasty’ has been improved and refined ever since the introduction of operative microscope. The methods of radical and modified radical mastoid operations have not changed for decades except for minor variations. The innumerable graft materials being used to restore the dry and functioning ear. The autologous, homologous and allograft, synthetic materials lik plastics, ceramics, hydroxyapatite and golds were used but none of these have established their universal acceptability as a proved graft except the autologous grafts (cartilage, ossicles, fascia). The functioning and survival of each graft material varies as each one has certain advantages ad disadvantages and technical problems during and after surgery.
Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction.

To date, temporalis fascia and perichondrium remain the most commonly employed materials for closure of tympanic membrane perforations.  The success rate in TM reconstruction with these materials approaches 90%. In certain situations, such as the atelectatic ear, cholesteatoma, and revision tympanoplasty, the results with these materials have not been as gratifying.  Fascia and perichondrium have been shown to undergo atrophy and subsequent failure in the postoperative period.  This has led to the use of cartilage, which is a less compliant, more rigid material that resists resorption and retraction.  It has also been shown by different studies that it is well tolerated by the middle ear and hearing results have been comparable with those of fascia and perichondrium

 We present our experince of twenty years (1980–2000) in using ‘Tragal Cartilage and Perichondrium’ in the reconstructive tympanoplasty. This study includes 600 cases of varied middle ear pathologies grouped in to four main divisions such as myringoplasty, ossiculoplasty, ossiousplasty (for defects in attic, posterosuperior quadrant, posterior canal wall and annular defects) and cavity obliterations. This study is not a comparative study to prove the superiority of any particular graft material over another.



Principles of Cartilage Tympanoplasty

This study includes 600 cases of varied middle ear pathologies of both safe and unsafe C.S.O.M. All cases were treated conservatively for prolonged time before being subjected for reconstruction. The special attention was paid to Eustachian tube function. The relevant investigations as routine otomicroscopy, mastoid X–rays, paranasal sinus X–rays, audiometries and blood biochemistry were done.


Study Design: 600 Cases


The study was designed in four groups. Group A – Myringoplasty (n=300), Group B–Ossiculoplasty (n=110), Group C – Ossiculoplasty (n=120), and Group D – Mastoid cavity obliteration (n=70) All cases were subjected for reconstruction after eradicating the middle ear pathology by various surgical approaches. The enomeatal (n=192), endaural (n=312), postaural (n=60) and transtympanic (n=36). The age group was 15 to 55 years and males were predominant. Most of these cases were done under local anaesthesia with sedation (n=480) and smaller group under general anaesthesia (n=120).

During the study it was observed that the middle ear showed different pathologies such as perforations (n=240), adhesive otitis media (n=24), tympanosclerosis (n=36) and cholesteatomas (n=120). Statistical Analysis was done in SPSS 10.0 using chi–square test.


.
CLASSIFIED GROUPS:


Group A - Myringoplasty (n=300):


Out of 300 cases onlay grafting was done in 172 cases and inlay grafting was done in 128 cases. The tragal perichondrium and catilage was the choice graft used with excellent post of results. The success rate was 96% and failures 4% in this group. The hearing gain with SRT was achieved within 15 dB AB gap closure. The failure of 4% were subjected to revision surgery. The dry and healed middle ear was seen within three months time. The failure cases were attributed to infection, unhygienic conditions,prosthesis displacement, graft rejection and  poor follow–ups. In this group the follow up was 2 to 6 yrs. Audiometric thresholds revealed 15–20 dB A–B gap closure. The follow up was achieved in 50% of cases for 2 to 4 years.





Group B– Ossiculoplasty (n=110) (Fig.1–6):


In this group all cases were subjected for tympanomastoidectomy with ossicular reconstruction by tragal cartilage and perichondrium struts of various types as L–shape, Bow–shape and Boomrang strut. Various combinations of Incudo–stapedial assembly, malleo–stapes strut, malleo–footplate assemblies were done. In all cases sialistic sheet was used so also the anterior canal skin as covering the graft assembly. In this group the success rate was 84% and failure rate was 16%. The failures were due to infection, prosthesis displacements and extrusion of the graft. Audiometric thresholds revealed 15–20 dB A–B gap closure. The follow up was achieved in 50% of cases for 2 to 4 years.

The technique used for cartilage reconstruction with ossiculoplasty depends on the presence or absence of the malleus manubrium. In the malleus present situation, the palisade technique is very effective and also provides good acoustic benefit. The malleus-absent situation represents one of the most challenging situations for cartilage tympanoplasty and ossicular reconstruction. The perichondrium/cartilage island flap is used in these cases to prevent the prosthesis touching the tympanic graft and preventing extrusion. In these cases, the anterior portion of the cartilage is held securely in place while the posterior half is folded out to expose the trailing edge of the anterior piece of cartilage, which acts, in effect, as a neo-malleus. The distance between the stapes footplate or suprastructure and this trailing edge is measured and the prosthesis is cut to the appropriate length. The posterior portion is unfolded.  The nice thing about folding the prosthesis in half is that you can visualize the prosthesis and have precise placement.




  Different ossicular defects and their correction by cartilage struts.























Group C– Osseusplasty (attic, PSQ, PCW, annular defects) (n=70):





 



Attic,marginal,post.superior quadrants defects(cholesteatoma)


Cholesteatoma represents one of the most controversial but important pathologic conditions in which cartilage is used. The primary purpose of cholesteatoma surgery is to eradicate disease and provide a safe, hearing ear. The magnitude of the controversy regarding optimal surgical care is beyond the scope of this presentation, but cartilage should arguably be involved in each technique. The palisade technique has been very useful in the cholesteatoma setting as it gives the opportunity, if needed, to perform an ossiculoplasty in a precise way. Also, some authors prefer to leave the anterior portion of the TM without cartilage for surveillance and possible tube placement, if necessary, in the postoperative period. However, cartilage placement in the posterior aspect of the TM can certainly delay a recurrence. but, in most series, cholesteatoma will recur in the anterior portion of the TM and it can be suspected in the setting of a recurrence in conductive hearing loss. After my review of literature, I found that the recurrence rate for cholesteatoma after cartilage tympanoplasty is less than 10%.  And if we compare this rate with cholesteatoma recurrence rate overall in children, we can appreciate that is much lower than rates previously reported in the literature which ranges from 10-46%

In this group the various defects of attic, posterosuperior quaderants, posterior canal wall and annular defects were closed by tragal perichondrium and cartilage grafts. The composite graft proved to be the best than nonbiological grafts in takeup and restoring dry ears. The cholesteatoma from the defect was removed and the defect was closed with the grafts. The posterior canal wall defect was reconstructed with the tragal cartilage graft and lined by perichondrum and anterior canal wall skin. This group achieved 75% success rate and 25% were failures which needed revision surgery.



Group D– Mastoid obliterations (n=120):




Mastoid obliterations

All mastoid cavities were preoperatively treated by suction clearance, dry mopping with antifungal and antibiotic drops for about 4–6 weeks. The cavities were fashioned by smooth drilling and removing all debris, pockets of cholesteatomas etc. the tragal cartilage was arranged in the palisade manner with the perichondrium coverage and the pedicled temporalis muscle was swinged to obliterate the mastoid cavities for good healing. Periodical follow up and aural toilet were done. The cavities re–epithelised well and achieved 70% success rate. 30% failures was because of infection and poor post op. follow ups. The modified radical mastoidectomy cavities were transformed into radical cavities to achieve good healing. The problems of mastoid cavities are still unresolved despite the treatment of various modified techniques being weak.

Table I – Age group in the study:
Age group (years) No. of cases Percent
15–25 168 28
25–35 264 44
35–45 120 20
45–55 48 08
Total 600 100

Table II: Sex distribution:
Age group (years) Male (no.) Female (no.) Total
15–25 108 60 168
25–35 120 144 264
35–45 72 42 120
45–55 24 24 48
Total 324 276 600
Percent 54 46 100


Table III – Surgical approaches:
Approaches No. of cases Percent
Endaural 312 52
Endomeatal 192 32
Postaural 60 10
Transtympanic 36 06
Total 600 100

Table IV – Anaesthesia:
Anaesthesia No. of cases Percent
General 120 20
Local + Sedation 480 80
Total 600 100


Table V – Pathological defects:
Type of Pathology No. of Cases %
Performation 240 40
Adhesive Otitis media 24 04
Tympanosclerosis 36 06
Retration pocket 180 30
Cholesteatoma 120 20
Total 600 100


Discussion:

Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction




Pathological-Defects

For many years the so called conservative methods of radical mastoid operations (Barany, Bondy, Citelli, Heerman, Stacke) were done in the clearance of disease but none of these proved better. At later dates Farrior, House, Lempert, Morrison added some minor variations in the technique of reconstructive tympanoplasty but still could not achieve the good results because the recurrence of the disease was very high. To modify these Victor Goodhill, Heerman and Heerman demonstrated their new techniques which prevented the recurrence of the cholesteatoma and gained the high success rates.


Distinct Advantages of Tragal Cartilage Graft

In this study 600 ear operations were performed with tragal perichondrium and cartilage as a composite graft in various types of middle ear reconstructions such as myringoplasty, ossiculoplsty, osseous reconstructions and mastoid obliterations. This study was done at K.E.M. Hospital E.N.T. department, Pune during 1980–2000. We have presented our observations of this reconstructive study of 20 years and found that the tragal cartilage is an ideal graft for the reconstructive middle ear surgery.

In the simple myringoplasty group the tragal perichondrium and cartilage achieved 96% success rate, the small, large and subtotal central perforations healed well in six weeks time. The inlay and onlay methods were used in the neotympanic reconstruction. In the total perforations and missing annulus the perichondrium angle was appropriate fit in forming the new annulus the perichondrium angle was appropriate fit in forming the new annulus. By this technique the blunting and lateralisation of the graft was prevented from the various cartilage assemblies in ossicular reconstruction achieved excellent stability and contact to bridge the gap in transformer mechanism. The incudostapedial gap was restored by cartilage sturt and maintained assembly. The malleostapedial, malleofootplate assembly proved good in restoring hearing.
 I

Ideal Graft

In TORP. & PORP ossicular graft the interposed tragal cartilage and drum have increased the ossicular stability and improved hearing to 75% (Victor Goodhill). Chronic endotympanic depression is a pathological entity which leads to atelectasis, retraction pockets and cholestestoma formation. The tragal cartilage and perichondrium composite graft intervention has prevented the recurrence of the cholesteatoma pocket adhesions and tympanosclerosis. The postop results were dryhealed middle ears with good hearing.



Results of Cartilage Tympanoplasty

During the study it was observed that middle ear patology of 40% perforaytions of safe and unsafe types, 4% adhesive otitis media, 6% tympaosclerosis, 30% retraction pockets and 20% cholesteatoma sacs. All these pathologies were corrected by radical removal and tragal cartilage reconstruction.

In mastoid obliteration the palisade cartilageplasty proved in gaining dry cavities in 70% of the cases. The Eustachian tubal obstruction was relieved by tunnelplasty and improved the good middle ear aeration. The cartilage bridge over promontory and hypotympanum assures the proper contact with stapes and in the combined approach tymparoplasty procedure the recurrence of cholesteatoma in the sinus tympani and facial recess could be prevented by incorporating the composite tragal cartilage and perichondrium. In open cavities the tympanocartige stapedopexy improved the hearing. It was our observation that biological material like tragal cartilage, perichondrium, facia or ossicles etc. are much better than nonbiological materials in reconstructive surgery.



Poor Results in Cartilageplasty


The survival rate of tgragal graft material is much better than nonbiological materials.

The extrusion rate of cartilage is very minimal as compared to the other graft materials. The review of literature revealed the different extrusion rates of different materials, such as autologous, 1.19%, isografts 3.06% the synthetics 5.04%, human dentine 7.14%, gold prosthesis 8.7%. Overall the tragal cartilage and perichondrium proved to be the best graft materials in reconstructive tympanoplasty which is universally accepted.




Table VIII :Extrusion rates of commonly used graft materials:
Graft material Extrusion rate (%)
Autograft 1.19
Isograft 3.06
Synthetic 5.04
Human Dentine 7.14
Gold prosthesis 8.70

Table IX :Results of cartilage tympanoplasty: P=0.0001 by chi square:
Group Success (%) Failure (%)
Myringoplasty 96 04
Ossiculoplasty 84 16
Osseusplasty 75 25
Mastoid obliteration 70 30

Table X – Poor results in cartilageplasty:
Causes No. of cases
Displacement 12
Fibrosis 10
Absorption 06
Infection 08
Total 36

TABLE V – Pathological Defects:
Type of Pathology No. of Cases Percet
Performation 240 40
Adhesive Otitis media 24 04
Tympanosclerosis 36 06
Retration pocket 180 30
Cholesteatoma 120 20
Total 600 100


Table VI – Ossiculoplasty:
Lesion No. of cases Percent
Attic 55 50
Posterosuperior quadrant 33 30
Posterior canal wall 11 10
Eustachian tube 11 10
Total 110 100

Table VII – Ossicular Status (300 cases): –P=0.0001 by Chi square:
Structure Normal Eroded Destroyed
Maleus 120 72 108
Incus 000 96 204
Stapes 108 00 192










 Conclusion

 The use of cartilage is experiencing a renaissance in ear surgery because it appears to offer an extremely reliable method for reconstruction of the tympanic membrane in cases of advanced middle ear pathology and Eustachian tube dysfunction.
Cartilage is particularly useful for the atelectatic ear, cholesteatoma, high risk perforation and for reinforcement of the tympanic membrane in conjunction with ossiculoplasty.
Hearing improvement can be experienced with the use of cartilage regarding the underlying pathology. Excellent clinical and experimental evidence exists to justify the use of cartilage as a grafting material in pediatric tympanoplasty. Cartilage tympanoplasty provides a tympanic membrane repair with greater structural stability and strength than traditional graft materials in many patients with challenging middle ear environments
In view of the above study we strongly recommend the tragal perichondrium and cartilage composite graft in various tympanoplasty reconstructions. The main reason being the cartilage is easily available at the site of operation, nontoxic, less, extrusion, minimum shrinkage, and lateralisation above all it is very cost effective to our patients. The hearing improvement within 15db of bone conduction has become almost a standard criterion for the analysis of surgical success.







Extrusion Rate of Commonly Used Graft Material


References:

Aeaham Evitor and Bronx NY: Tragal perichondrium and cartilage in reconstructive ear surgery, Laryngoscopy, 88 (Suppl.): 1–23,1978.
Heerman and Heerman tympanoplasty and mastoidoplasty, Laryngorhinootology, 46:370–382, May 1968.
Plester D.: Myringoplasty methods, Archieves otolaryngology, 78:310–316, Sept.1963.
House H. P.: Surgical repair of the perforated drum, Annales otorhinolaryngology, 62 : 1072–1093, 1956.
Goodhill Victor, Harris I., and Brockman S. J.: Tympanoplsty with perichondrium graft, Archieves otolaryngology, 79, 131, 1963.
Claus Jansen : Cartilage tympanoplasty, Laryngoscope, 73: 1288, 1963.
Heerman and Heerman: Fascia and cartilage palisade tympanoplasty, Archieves otology, 91 : 228–241, 1970.
Victor Goodhill: Tragal perichondrium and cartilage in tympanoplasty, Archieves otology, 85:480–491,1963.
Jansen C.: Use of perichondrium for tympanoplasty, Archives ohren, 182:610–614, 1963.
Shea J. J.: Vein graft in tympanic reconstruction, Journal of laryngootology, 74:358–362, 1960.
Contributed by Dr. K. K. Desarda

PRIMARY RHINOSPORIDIOSIS OF NASOPHARYNX.

                             PRIMARY  RHINOSPORIDIOSIS  OF NASOPHARYNX.

                                  DR.K.K.DESARDA. DR. SHEETAL.DR.NEELIMA.
                                                       KEM HOSPITAL PUNE.


                  
Abstract.

A rare case of primary Nasopharyngeal rhinosporidiosis with extension to nasal cavity,maxillary sinus anteriorly and posteriorly extending to oropharynx is reported in a young male patient. The pathophysiology, clinical feature, diagnosis and management of this condition are reviewed.
Key words: Rhinosporidiosis, Rhinosporidium Seeberi

Indroduction:

Rhinospordiosis is a chronic granulomatous disease characterized by production of polyps or other manifestations of hyperplasia on mucous membrane surfaces, the etiologic agent being Rhinosporidium seeberi. The disease was First described  by seeber (1900) in Argentina. This noval pathogen commonly affects mucosa of nose, eye and upper aero-digestive tract of men and animals. Isolated deep seated Rhinosporidiosis is rare. Diagnosis is mainly based on clinical suspicion and histopathological confirmation. At present, no existing medical treatment cures the disease and endoscopic excision of the mass with cauterization of the base is considered as treatment of choice.

Case Report

A 45 year old male patient came to us with history of left nasal obstruction,epistaxis, distorted speech with nasal twang and intermittent dysphagia and headache for over 6 yrs He was treated at the local district hospital but without great relief.
The patient did not give any history of TB,DM and any majot illness in past apart from nasal obstruction , intermittent nose bleeds,and nasal speech with poor intake of food.. patient was chchectic with mild pallor, with a pulse rate of 84/minute, regular, BP-100/80 mmHg, CVS-NAD, Chest:-NAD.


Investigations:

Hb%-8.0gm% ,TLC 8000/mm ,DC-N80%,L-18%,E-2%,ESR-5mm.
Serum urea 30mg%,serum creatinine-1.42%,Urine –NAD,
AbsAg –negative,Anti HCV-negative,Elisa for HIV-negative,serum Bilirubin0.6mg%
SGPT and SGOT within normal limits

DC:-N-82%, L-17%, E-01%
FBS:-106 mg%
ESR:- 5mm in 1st hr,
Sr.
Radiological investigations: x-ray chest NAD,CT coronal PNS revealed Hughe mass occupying left maxilla,OMU blocked with mass. The mass was occupied in the nasal cavity, nasopharynx with extension to oropharynx.FNAC done for HP. Examination.which revealed rhinospordiosis.
Nasal endoscopy revealed pinkish mass occupying left nasal cavity,nasopharynx and left maxilla. and mass was,protruding in to oropharynx ,pushing the palate anteriorly.The septum was pushed to right   causing  nasal obstruction.. Clinical diagnosis of Rhinospordiosis.was made.
Patient was advised surgery and subsequently undergone endoscopic excision.
Nasal endoscopy revealed pinkish mass occupying left  nasal cavity,nasopharynx and protruding in to oropharynx,pushing the palate anteriorly. The mass bled during the clearance. Complete endoscopic clearance of the naso-maxillary-and nasopharynx was done. The complete haemostasis secured.by cauterization.The anterior and post nasal packing with BIPP was done .The  enblock specimen was sent  for histopathological examination. Post op recovery was uneventful.
Patient was given broad spectrum antibiotic,anti inflammatory agents and Dapsone theray . He was advised to continue Dapsone theray 100mg OD for six months and attend follow up clinic every 3 months for any recurrence.
    Rhinosporidosis  post surgery specimen.
   
  Enblock  resection of  Rhinosporidium of Naso-oro pharynx.
    Histopathlogy:
                                             
 H&E stain of nasal polyp showing two mature sporangia and
several immature ones with a single centrally placed spore.



.
DISCUSSION:

Rhinosporidiosis is a chronic granulomatous disease characterized by production of polyps or other manifestations of hyperplasia on mucous membrane surfaces. The etiologic agent is Rhinosporidium seeberi.Most of the early studies of rhinosporidiosis were made in India and Ceylon where the disease occurs frequently. Sporadic case have been detected and studied in many parts of the world. The systematic position of R. seeberi is still uncertain. Most investigatrs consider it has not been isolated in culture.
 Friable, highly vascular, sessile or pedunculated polyps may appear on almost any mucosal surface, and rarely secondary lesions are found on skin, probably as aresult of autoinoculation by scratching. Lesions of the mucosae often spread by extension beyond the mucocutaneous border.
Primary lesions appear most often on the nasal mucosa and are accompanied by painless itching and a profuse mucoid discharge. The lesion is at first flat and sessile. Later hyperplastic growth greatly exceeds lateral extension of the lesion so that a polypoid mass much larger than the peduncle develops. The polyp may extend from the neres into the pharynx or externally over the lip and may reach weight of 20grams. It is friable and bleeds freely after trauma. Its surface is mucoid and papillate or so lobulate that its surface suggests that of a cauliflower. The color varies from pink to purplish red, and close examination of the surface mayh reveal minute white sports which are the mature sporangia of the fungus.
Lesions of the eye may cause symptoms similar to those produced by a foreign body, lacrimation or photophobia. Growth of the polyp may cause eversion of the lid. Lesions on th eskin being as papillomas and become warty with inclusions of myxomatous material. They are relatively painless except when on the sole of the foot and when they become so large as to be uncomfortably heavy. Dissemination to visceral organs is rare.

Differential diagnosis:

Typical lesions of rhinospordiosis can be recognized usually by the pink to purple colour, friable consistency and the presence of barely visible white sporangia within the polyp. Atypical lesions or those in unusual anatomical sites must be differential from warts, condylomata and hemorrhoids.

Immunology:

Little is known about the immunology of rhinosporidiosis.
Pathology:
H&E stain of nasal polyp showing two mature sporangia and
several immature ones with a single centrally placed spore

On the examination of the gross tissue, unless rhinosporidiosis has been suggested by the clinician, or by the history of the patient's geographic residence, the pathologist may consider the specimen an ordinary nasal polyp. The correct diagnosis can usually be made without difficulty on examination of routine H and E stained slide. Under the scanning lens of the microscope, although the polypoid structure may be evident, the histopathologic pattern differs greatly from tht of the common nasal polyp. The most striking feature is the presence in the stroma or epidermis of numerous sharply defined globular cysts which usually vary from 10 to 200.. Some of the cysts may be partly collapsed, assuming a semilunar shape. In contrast to the loose, edematous, myxomatous stroma of the ordinary nasal polyp, the stroma in rhinospordiosis is rather dense. There is a chronic inflammatory reaction in which neutrophils, plasma cells and lymphocytes are prominent. In contrast to the usual nasal polyp. Eosinophils are inconspicuous. Occasionally purulent microabscesses occur.
The cysts of all size have a sharply defined chitinous appearing wall. In a large maturing cyst the wall alone may be 5  thick. Histologically, rhinosporidiosis should be differentiated, specially in immuno-suppressed persons with other fungal infection like Coccidioides immitis.

Epidemiology:

Although rhinosporidiosis is seen most often in children and young adults, it occurs at any age. No racial difference in susceptibility are recognized. The disease is seen much more frequently in men than in women, but the extent to which this difference is related to greater frequency or severity of exposure is difficult to evaluate. Infections are seen most often in labourers and in those with frequent exposure to water of streams and pools.

Geographic distribution:
Rhinosporidiosis is found must often in India and Ceylon, but it is reported also from the East Indies, the Malay, States, the Philippines, Iran, South Africa, Italy, England, Scotland, Southern United States, Mexico, Cuba, Argentina, Brazil and Paraguay.
Source of infection:
The disease is not contagious, and sources of infection are exogenous. The frequent history of prior extended to water of pools and rivers and the occurance of multiple cases among those members of a group of workmen most intimately and repeatedly exposed to water source suggest the R. seeberi has a natural habitat in water. Rhinosporidiosis was observed in workmen who dived under water to bring up san din buckets, but not in their associates who carried the sand from the water's edge. It has been suggested that water insects or fish may be hosts of the fungus.

Laboratory diagnosis:

Direct examination of the surface of the polyp may reveal the subsurface position of sporangia which are white and so large (up to 350  in diameter) that thery can be seen with naked eye. Dissection of sporangia or excision and microscopic examination of tissue confirms the diagnosis. Culture is not successful, and the inability of R. seeberi to grow on artificial media, as well as some peculiarties about its reproductive cycle in tissues, have raised the question whether it is actually a fungus.
It is resembles in general appearance and in manner of sporulation some species of synchytrium, which are obligate parasites of plants, and which produce characteristic galls on the host plant. Animal inocultion is not helpful in diagnosis. Although R.seeberi is found in natural infections of horses, mules and cows, experimental infections usually do not succeed. Recently molecular methods like polymerase chain reaction are being developed for diagnosis.

Conclusion:
 Rhinosporidiosis, a fungal infection due to Rhinosporidium seeberi, frequently produces polypoidal lesions in the nose. Sites like the conjunctiva, larynx, trachea, nasopharynx, skin and genitourinary tract are less frequently involved. Generalized rhinosporidiosis with skin and visceral involvement is extremely rare... Smears revealed numerous sporangia and spores of R seeberi. There were no mucocutaneous lesions. Histologic examination confirmed the  diagnosis of Rhinospordiosis.  The FNAC diagnosis of rhinosporidiosis is specific. Preoperative diagnosis is possible even in cases with unusual clinical presentations.
Rhinosporidiosis should be suspected or considered in all cases of swellings of nose,
 nasopharynx and skin. Although disseminated Rhinosporidiosis is very rare, still
remains a possibility and requires a different mode of treatment. Presently the medical
treatment of Rhinosporidiosis is not satisfactory and requires further study and
research.Meanwhile patients should receive Dapsone therapy for over six months.


References:
1. Caldwell, G.T. and Roberts, J.D.: Rhinosporidiosis in the United States J.A.M.A. 1938; 110,1964.
2. Karunaratne W.A.E.: Rhinosporidiosis in Man, London, Athlone Press, 1964.
3. Weller, C.V. and Riker, A.D.: Rhinosporidiosis in Man, London, Athlone Press, 1964.
4. Weller, C.V. and Riker, A.D.: Rhinosporidiosis seeberi Am.J.Path, 1930,6,721-732.
5. Baron, E.J., Peterson, L.R. Finegold, S.M. New, Controversial difficult-to-cultivate or non-cultivate etiological agents of disease in Bailey and Scott's Diagnostic Microbiology, 9th Edition, Mosby, st.Louis, Baltimore, Boston, 1994; p-585.

DIODE LASER TREATMENT IN ORAL SUBMUCOUS FIBROSIS.


DIODE LASER TREATMENT IN ORAL SUBMUCOUS FIBROSIS.
(KEM-PUNE STUDY)
Dr.K.K.DESARDA.
Abstract:
Oral submucous fibrosis (OSMF) is a high-risk pre-cancerous condition characterised by slowly progressive chronic fibrotic disease of the oral cavity and oropharynx, in which the oral mucosa loses its elasticity and develops fibrous bands, which ultimately leads to difficulty in opening the mouth. The malignant transformation rate of oral submucous fibrosis is as high as 7.6%. A wide range of treatments such as medical management, surgical therapy and physiotherapy have been attempted in the past with varying degrees of benefit, but none of them have been proved to be a conclusive method of treatment. . There are very few reports to correlate the clinical stage to histopathological grading in OSMF.The aim of our study was to relive trismus caused by submucous fibrosis,to evaluate the efficacy of diode laser therapy without any grafting procedures, and to maintain mouth opening with props physiotherapy.
 A hospital-based study was conducted on 65 OSMF cases who visited ENT dept. KEM Hospital Pune from 1990 -1996. A detailed history of each patient was recorded along with a clinical examination. Biopsy was performed for histopathological correlation.We have  tried all modalities like diathermy excision,skin grafts.tongue flaps,palatal flaps but without much  benefits in improving trismus for our patients  and  lastly  we adopted  Diode surgical therapy  with spring props for physiotherapy  which proved excellent  treatment in improving trismus.
Key words: submucous fibrosis, Diode laser,props,skin grafts,tongue flaps.
Email:kdesarda@gmail.com
Adress: Dr.K.K. desarda.
Prof.Emeritus & Head Otolaryngology,
KEM Hospital’Pune, India.
Inroduction:
On the Indian subcontinent, the use of smokeless tobacco in various forms is very popular. This habit, which usually involves the chewing of a betel quid (combined areca nut, betel leaf, tobacco and slack lime), has led to the development, in a large proportion of users, of a unique generalized fibrosis of the oral soft tissues, called oral submucous fibrosis.The condition is found in 10/1,000 adults in rural India and as many as 5 million young Indians are suffering from this precancerous condition as a result of the increased popularity of the habit of chewing pan masala.  Pan masala is a mixture of spices including, betel nuts, catechu, menthol, cardamom, lime and others.  It has a mild stimulating effect and is often eaten at the end of the meal to help digest food and feel comfortable.
Oral submucous fibrosis is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the submucosal tissues (lamina propria and deeper connective tissues).  Oral submucous fibrosis results in marked rigidity and an eventual inability to open the mouth.  The buccal mucosa is the most commonly involved site, but any part of the oral cavity such as the soft palate, pterygomandibular raphe, the anterior pillars of fauces and even the pharynx can be involved.
 The treatment of patients with oral submucous fibrosis depends on the degree of clinical involvement. If the disease is detected at a very early stage, cessation of the habit is  sufficient. Most patients with oral submucous fibrosis present with moderate-to-severe disease which is irreversible. Medical treatment is symptomatic and predominantly aimed at improving mouth opening.. We have  treated stage II  with medical treatment and injection kenacort for six weeks and  Stage III  & iv with severe fibrosis + trismus + dysphagia with Dioded laser therapy and achieved excellent results with inter-incisor opening ranging between 32 to 36 mm .
Because of developments in Diode Laser technologies, it has found great applications in surgery due to improved power and precise controllability. It has found great applications in oral surgery practice as well as in other areas. By changing the wavelengths we can control the energy levels and other desired properties that determine incision quality and coagulation parameters.
PATHOGENESIS OF ORAL SUBMUCOUS FIBROSIS:
    ;

Diode lasers built with semiconductor materials are portable and very compact in size and can be used in different modes such as pulsed or continuous mode. Diode laser surgery can be successfully used in surgical treatment of Submucous fibrosis. On the Indian subcontinent, the use of smokeless tobacco in various forms is very popular. This habit, which usually involves the chewing of a betel quid (combined areca nut, betel leaf, tobacco and slack lime), has led to the development, in a large proportion of users, of a unique generalized fibrosis of the oral soft tissues, called oral submucous fibrosis.The condition is found in 10/1,000 adults in rural India and as many as 5 million young Indians are suffering from this precancerous condition as a result of the increased popularity of the habit of chewing pan masala.  Pan masala is a mixture of spices including, betel nuts, catechu, menthol, cardamom, lime and others.  It has a mild stimulating effect and is often eaten at the end of the meal to help digest food and as a breath mint.1
Oral submucous fibrosis is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the submucosal tissues (lamina propria and deeper connective tissues).  Oral submucous fibrosis results in marked rigidity and an eventual inability to open the mouth.  The buccal mucosa is the most commonly involved site, but any part of the oral cavity such as the soft palate, pterygomandibular raphe, the anterior pillars of fauces and even the pharynx can be involved.The condition is well associated with areca nut chewing; a habit practiced predominately in Southeast Asia and India. Worldwide, estimates of oral submucous fibrosis indicate that 2.5 million people are affected, with most cases concentrated on the Indian subcontinent, especially southern India.  The rate varies from 0.2-2.3% in males and 1.2-4.5% in females in Indian communities.  The migration of endemic betel quid chewers has also made oral submucous fibrosis a public health issue in many parts of the world, including the United Kingdom, South Africa, and many Southeast Asian countries.
A variety of aetiological factors including capsaicin, betal nut alkaloids, hypersensitivity, autoimmune genetic predisposition  and malnutrition have been suggested by various authors.The importance of this disease lies in its inability to open the mouth and dysplasia giving rise to malignancy.  The incidence of malignant change to squamous cell carcinoma in patients with OSMF ranges from 2 to 10%. Submucous fibrosis typically affects the buccal mucosa, lips, retromolar areas and the soft palate. Occasional involvement of the pharynx and esophagus is seen. Early lesions present as a blanching of the mucosa, imparting a mottled, marble-like appearance. Later lesions demonstrate palpable fibrous bands running vertically in the buccal mucosa and in a circular fashion around the mouth opening or lips.  As the disease progresses the mucosa becomes stiff, causing difficulty in eating and considerably restricting the patient's ability to open the mouth (trismus). If the tongue is involved, it becomes stiff and  atrophic.
Mucosal petechiae are seen in more than 10% of cases and most patients complain of a burning sensation, often aggravated by spicy foods.  Salivary flow is diminished and blotchy melanotic mucosal pigmentation is often seen. More than a fourth of affected persons develop precancerous leukoplakia of one or more oral surfaces. Once present, oral submucous fibrosis does not regress, either spontaneously or with cessation of betel quid chewing.Histologic findings in oral submucous fibrosis are generally characterized by diffuse hyalinization of the subepithelial stroma, atrophic epithelium and intercellular oedema, with or without keratosis, epithelial dysplasia, chronic inflammation and fibrosis in the minor salivary glands in the area of quid placement; and atrophy of the underlying muscle.
MATERIALS AND METHODS
  A total of 65 histologically proven cases of advanced oral submucous fibrosis having a mouth opening of less than 10 mm were treated by Diode laser excision. The procedure involved (1) bilateral release of fibrotic bands  .(2)extraction of bilateral upper and lower molars .3) Temporary acrylic prosthesis insertion between upper and lower molars bilaterally. 4) after six weeks patients were given spring prosthesis for extensive physiotherapy. 5)  Pre and post operative inter-incisors distances were measured  by caliper and recorded.6) supportive IV fluids, vitamins. and antioxidants therapy was continued for further three months. 7) Regular followup was done and results were assessed by comparing the  different modalities  responses in preoperative & postoperative maximum mouth opening.8) No grafting  procedures were  done in our series for the scarred tissue. 9) Post op healing was excellent.
        TABLE-1, Age group & sex Ratio:
       
     
  TABLE-2. Clinical staging and grouping:
Group I Earliest stage witht mouth opening limitations with an interincisal distance of greater than 35 mm.
Group II Patients with an interincisal distance of 26-35 mm.
Group III Moderately advanced cases with an interincisal distance of 15-26 mm.
Group IVA   Trismus is severe, with an interincisal distance of less than 10 mm
Group IVB Disease is most advanced, with  dysphagia  & premalignant and malignant changes in the mucosa
 
      TABLE-3 Grouping of Different modalities treatment result wise:
Grouping Procedure Cases Result
Group 1 Simple diatheramy excision                 25 cases             Triusmus opening short term with scarring
Group 2 Skin grafting                                       15 cases             High failure because of flap necrosis
Group 3       Tongue flaps                                       10 cases             Initial results good but very cumbersome for pts. Tongue flap necrosis, speech problems
Group 4 Diode laser therapy                           15 cases             Excellent long term results with improved                                    

Pre-Operative pictures of OSMF
                                       
Early branching in OSMF                Depapilliation of Tongue             severe blanching of tongue                   Bud-like uvula in OSMF        
                                                                   
                                     
        Buccal Lesion                                  Lower lip lesion                                Tongue lesion                              Retromolar lesion.

      Diode Laser Procedure:.

Under GA with tonsillectomy position the mouth gag(Boyle Davis) is inserted inthe oral cavity and the last upper and lower molars on either sides extractedand haemostasis secured. Next with Diode Laser the fibrotic bands from retromolar region to soft palate ,anterior and posterior tonsillar pillars and uvula were excised.Laser beam with ideally 5 watt power is directed. to the fibrotic bands .The excision of fibrous bands was followed by forcible separation of mucosa.using  Boyl davis gag  and oral cavity  opening stretched .at its maximum..After complete haemostasis the oral cavity is cleaned and temporary acrylic prosthesis is inserted  bilaterally between the last  upper and lower molars., and maintained for full 10 days.Post operative Ryles tube feedig continued for ten days . During the post op period  oral hyegine was mainted. After the oral mucosa has healed well ,the patients were given  spring props for for extensive physiotherapy.for further six weeks.All Patients were instructed to stop chewing betel nuts or other addictive habits. Patients were taught mouth opening exercises with this spring props six to eight times day along with chewing gums exercises.The inter- inscisor measurement were recorded. All patients were given i.v.antibiotics,anti inflammatory drugs for controlling the oral sepsis and pain . Patients were followed at an interval of 2 months, 6 months and 1 year where by interincisor distance was measured and documented..
Results
In our series  65 patients were studied from age 16 years to 60 years (Mean 32years) who were habitual betel nut chewers. Males had preponderance of 68%and females of 32%. The Mean maximum mouth opening of the patients preoperatively was 10 mm. The Mean intra operative interincisor distance after fibrotic band excision was 32mm. Two months postoperatively the average mouth opening was 34 mm.and at 6 months 36 mm, and at 1 year 34mm. Patients were very happy and satisfied after this treatment.Since there is no effective treatment for oral submucous fibrosis and the conditionis  is irreversible  we have decided to adopt to Diode laser therapy which gave excellent results. All patients were kept for periodical observation and  surface leukoplakias are handled by close follow-up and  repeat biopsies for malignment change.

Submucous Fibrosis pictures showing post-operative
                                                     
  Diode laser instrument            Pre-surgical Markings             Intra of Temporary prosthesis                   Post of spring prosthesis       Post operative final opening    
     Discussion
Oral submucous fibrosis is a chronic debilitating disease associated with restricted mouth opening and poor oral hygiene.   The treatment aims at good release of fibrosis and provides long term results in terms of mouth opening.  The various conservative treatments with intralesional injections of steroids,  (kenacort) ,hyaluronidase, placental extract and physiotherapy are not beneficial to provide a long-term effect in advanced cases of oral submucous fibrosis   Surgical intervention is required in these cases.  The surgical treatment commonly followed is the release of bilateral fibrotic bands with  surgery and various grafts, tongue flaps, etc were tried but not much of benefit.
A mucosal graft is the best treatment for oral submucous fibrosis, as it is ideal graft to cover the oral mucosa, but is limited by the quantity of oral mucosal available for grafting.  Thick mucosa taken from the cheek may result in scar formation, whereas a uniform thin graft removed with a microtome from the cheek is costly and complicated.  Split-skin grafting has been tried but it has a high failure rate as fibrotic areas have less vascular supply besides retaining the coloration of skin.  Also seen is the growth of hair and sweat glands.  Skin is not suitable for grafting in elderly people due to atrophy and inelasticity.
A nasolabial flap has also been used by some surgeons and has a good survival rate, but sometimes it may be too small to cover the whole defect.  It also causes a visible scar on the face and requires a second surgery for division.   Tongue flaps are bulky and when used bilaterally causes disarticulation, dysphagia and increases the chance of aspiration.   In addition, the tongue is involved with the disease process in 38% cases   The use of bilateral, small, bipaddical radial forearm flaps for reconstruction of bilateral buccal defects requires two flaps with two microsurgeries.  The procedure is more time consuming and technically demanding, and it involves two forearm donor sites with sacrifice of the radial arteries in both the right and left hands.  Island palatal flaps again have limitation to reach posteriorly.
Of the 65 cases of OSMF studied, males were more than females. A literature survey shows a wide variation in age and sex distribution of OSMF. Some of the epidemiological surveys in India have shown a female predominance in the occurrence of this entity. A male predominance in OSMF cases was shown by Sinor et al.in India. We also observed a male predominance and the male to female ratio was 6:1. Half of the study population was in the age group of 20-29 years. This observation is different from that of Pindborg et al. who reported the maximum number of OSMF cases in the age group of 40-49 years in their study. Increase in the chewing habit of the areca nut without any tobacco and the use of various commercial products containing areca nut may explain the decrease in the age of OSMF cases due to various chewing habits. The mean age of occurrence was lower in males than in females and the difference was statistically significant (P<0.009).

Recent epidemiological studies in India and evidence from Indians living in South Africa point to the habit of chewing areca nut as the major aetiological factor of OSMF. In recent years, commercial preparations like paanmasala have become available in India and abroad. The main ingredient of these products is areca nut along with lime and catechu wrapped in a betel leaf with or without tobacco. Many patients with OSMF give a history of chewing paanmasala for very long time.
Seventy-five per cent of the patients in stage II had a habit of chewing commercially available areca nut products-"Paanmasala" and 50% of the total study population were in the age group of 20-29 years. It has been documented that paanmasala chewing was preferred by people in younger age groups (11-30 years). In addition, onset of OSMF changes occurred earlier with paanmasala chewing compared with areca nut / quid chewing. Absence of betel leaf, which has anti-oxidant properties and a consequently higher dry weight proportion of areca nut were responsible for early development of OSMF. These findings are of great concern because younger individuals are at greater risk as it has been well established that OSMF is a premalignant and crippling condition of the oral mucosa.
 The treatment aims at good release of fibrosis and provides long term results in terms of mouth opening.  The various conservative treatments with intralesional injections of steroids, hyaluronidase, placental extract and physiotherapy are not beneficial to provide a long-term effect in advanced cases of oral submucous fibrosis   Surgical intervention is required in these cases.  The surgical treatment commonly followed  in our series is the release of bilateral fibrotic bands with Diode Laser.with extraction of both upper lower molars  followed by post op.props for  extensive physiotherapy. We have achieved excellent results in all cases.
Conclusion
In this study, the occurrence of OSMF was higher in the younger age group of 20-29 years. The prevalence of OSMF was more in males than in females with a ratio of 6:1. The number of patients with a paanmasala chewing habit (68.0%) was higher than the number of patients with betel nut (17.4%) or betel quid chewing habits (14.6%). The chewing of paanmasala was associated with earlier presentation of OSMF as compared to betel nut chewing. Significant and direct correlation to the manifestation of OSMF was seen with frequency rather than duration of chewing.

The maximum number of patients (74.3%) as well as most of the paanmasala chewers were in clinical stage II. Although various degrees of epithelial dysplasia were observed, malignant transformation was not seen. There was no correlation between clinical staging to histopathological grading. This observation could be explained by the fact that patients with higher histopathological grading could have had more collagenous bands in the posterior region, which restricted the mouth opening. Chronic inflammatory cell infiltrate was observed in a large number of cases in histopathological grade I but less so in higher histopathological grades, possibly due to a stabilisation of the lesion and a decrease in the levels of proinflammatory mediators.   The follow up examinations after the surgery showed significant improvement in  mouth opening . The key point was extensive physiotherapy to sustain the mouth opening.  There is no doubt that diode laser surgery is very effective and less invasive technique to treat Submucous fibrosis and offers great relief to the terrible state the patients suffer because of this disease .This technique has less morbidity and is suitable for Asian population as it requires less hospital stay and less followup as compared to other surgical methods.
 
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