Department of Pathology, Saidu Group of Teaching Hospital (SGTH), Swat, Khyber Pakhtunkhwa, PakistanPakistan
Department of Pathology, Peshawar Medical College, Peshawar, Khyber Pakhtunkhwa, PakistanPakistan
Department of Health, Peshawar, Khyber Pakhtunkhwa, PakistanPakistan
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Objective To compare the efficacy of open mastoidectomy versus mastoidectomy with temporalis fascia flap obliteration in achieving postoperative dry ear chronic suppurative otitis media (CSOM) is a perforated tympanic membrane with persistent drainage of pus from the middle ear lasting more than 2-weeks. The global burden of illness from CSOM is estimated to involve about 65 to 330 million individuals with draining ears, 60% of them suffer from significant hearing impairment. Ninety (90) percent of burden is borne by developing countries, in Southeast Asia, the Western region of Africa. CSOM can occur with or without cholesteatoma, and the clinical history of both conditions can be very similar. The treatment plan for cholesteatoma always includes tympanomastoid surgery with medical treatment as an adjunct. The treatment plan for cholesteatoma always includes tympanomastoid surgery. After mastoidectomy the otologists facing mastoid cavity related problems such as otorrhoea, hearing loss. A variety of techniques have been proposed to perform obliteration. Methods Study design Randomized Controlled Trial. Setting Department of ear, nose, and throat (ENT), Head & Neck Surgery, Saidu Group of Teaching Hospital, Swat, Khyber Pakhtunkhwa, Pakistan. Duration of study From Jan, 2019 to 17 July, 2021. Sample size Randomly assigned patients with evidence of atticoantral disease to two groups, 47 in each group. After canal wall down mastoidectomy in Group A cavity left without obliteration, in Group B a superior based vascularized temporalis facial flap was used to obliterate the resultant mastoid cavity and they were followed up to 8-weeks. Results As per efficacy of both groups is concerned, in Group A, 34 (36.17%) patients had achieved post-operative dryness on 8th week of mastoidectomy whereas in Group B, 40 (42.55%) patients achieved post-operative dryness of ear on 8th week subject to mastoidectomy with temporalis fascia flap obliteration. (p value=0.130). Conclusion Patients who underwent mastoidectomy with temporalis fascia flap obliteration yielded better results in comparison to patients who underwent open mastoidectomy. Further the common organism were found in our region Staph Aureus and Bacteriodes and Proteus mirabilis.
Keywords: Chronic suppurative otitis media (CSOM); Mastoidectomy; Ear; nose; and throat (ENT)
Study design Randomized Controlled Trial.
Department of ear, nose, and throat (ENT), Head & Neck Surgery, Saidu Group of Teaching Hospital, Swat, Khyber Pakhtunkhwa, Pakistan.
Duration of study From Jan, 2019 to 17 July, 2021.
Sample size Randomly assigned patients with evidence of atticoantral disease to two groups, 47 in each group. After canal wall down mastoidectomy in Group A cavity left without obliteration, in Group B a superior based vascularized temporalis facial flap was used to obliterate the resultant mastoid cavity and they were followed up to 8-weeks.
As per efficacy of both groups is concerned, in Group A, 34 (36.17%) patients had achieved post-operative dryness on 8th week of mastoidectomy whereas in Group B, 40 (42.55%) patients achieved post-operative dryness of ear on 8th week subject to mastoidectomy with temporalis fascia flap obliteration. (p value=0.130).
Patients who underwent mastoidectomy with temporalis fascia flap obliteration yielded better results in comparison to patients who underwent open mastoidectomy. Further the common organism were found in our region Staph Aureus and Bacteriodes and Proteus mirabilis.
Chronic suppurative otitis media (CSOM); Mastoidectomy; Ear, nose, and throat (ENT).
C hronic suppurative otitis media (CSOM) is a perforated tym panic membrane with persistent drainage of pus from the middle ear lasting more than 2-weeks. 1,2 The global burden of illness from CSOM estimated to involve about 65 to 330 million individuals with draining ears, 60% of them were suffers from significant hearing impairment. Ninety (90) percent of burden is borne by developing countries, in Southeast Asia, the Western region of Africa. CSOM can occur with or without cholesteatoma, and the clinical history of both conditions can be very similar. The treatment plan for cholesteatoma always includes tympanomastoid surgery with medical treatment as an adjunct.3-5 The yearly incidence of CSOM, to be 39 cases per 100,000 persons in children and adolescents aged 15-years and younger. In Britain, 0.9% of children and 0.5% of adults have CSOM. In Israel, only 0.039% of children are affected. Other populations at increased risk include children from Guam, Hong Kong, South Africa, and the Solomon Islands.6-12 The anatomy and function of the eustachain tube play a significant role in the increased risk. The eustachain tube is wider and more open in these populations than in others, thus placing them at increased risk for nasal reflux of bacteria common to acute otitis media and recurrent acute otitis media and leading to more frequent development of CSOM.13-17 Certain population subsets are at increased risk for de veloping CSOM. The Native American and Eskimo populations demonstrate an increased risk of infection. Eight percent of Native Americans and up to 12% of Eskimos are affected by CSOM.18,19 The prevalence of CSOM appears to be distributed equally between males and females. Exact prevalence in different age groups is unknown; however, some studies estimate the yearly incidence of CSOM to be 39 cases per 100,000 in children and adolescents aged 15-years and younger.20
Randomized Control Trial.
Department of ear, nose, and throat (ENT) and Head and Neck Surgery, Saidu Group of Teaching Hospital, Swat, Khyber Pakhtunkhwa, Pakistan.
From January, 2019 to July, 2021.
Sample size was calculated by using World Health Organization (WHO) calculator with following parameters. Level of significance 5%, Power of test 80%, P1=90% and P2=70%.
Sample size, N=94 Group A=Patients undergoes mastoidectomy.
Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration.
Sampling T echnique Non-probability consecutive sampling (Block randomization).
Inclusion criteria: 1. Patient suffering from chronic suppurative otitis media, atticoantral (Squamous) disease; 2. Underwent radi cal and modified radical mastoidectomy; 3. Age gender is 15-years and less than 60-years; 4. Complete removal of cholesteatoma and granulations during surgery.
Exclusion criteria: 1. Patient having an intracranial complication of chronic suppurative otitis media; 2. Patient having facial nerve palsy and granulation arising from facial nerve; 3. Mastoidectomy performed for conditions other than chronic suppurative otitis media.
Patients fulfilling the inclusion criteria and scheduled for mastoidectomy were selected from the Department of ENT, Head and Neck Surgery, Saidu Teaching Hospital, Swat, Khyber Pakhtunkhwa, Pakistan. Patient’s demographic data along with registration number was entered on the proforma. After the informed consent, explaining procedures, its benefits and complications to the patients and then was randomly assigned into two groups based on lottery method. Group A will undergo open mastoidectomy and Group B will undergo mastoidectomy with temporalis fascia flap obliteration. Follow-up was done after a 8-weeks interval. From both groups the pus were collected from the affected ears, through standard aseptic technique. The collected pus samples were placed in an aerobic jar and transported within one hour to the pathology Department of SMC/Saidu Group of Teaching Hospital (SGTH) for routine microbiological culture and identification.
Subjective assessment was done by finding out from patients about the absence or presence of discharge and objective assessment was done by microscopy to assess the presence or absence of discharge in the operated ear.
Data was collected by the author and an experienced consultant who have performed all the procedures.
All the data was recorded on the proforma and subjected to analysis to measure the objectives.
Data was entered and analysed in statistical package for the social sciences (SPSS) version 20. Categorical variables like gender were described in frequency and percentages. Quantitative variables like age were described in mean+standard deviation. Chi-square (χ 2) test was used to determine the difference in proportion in two groups and p<0.05 was considered significant.
Age distribution, in Group A, 15 (15.95%) patients recorded in the 15-30-years age group. In age group 31-45-years, 15 (15.95%) patients were recorded whereas 17 (18.08%) patients were recorded in age group of 46-60-years. In the same manner, in Group B, 15 (15.95%) patients were recorded in the 15-30-years age group. In age group 31-45-years, 15 (15.95%) patients were recorded whereas 17 (18.08%) patients were recorded in age group of 46-60-years (Table 1).
We collected different types of microorganisms and found that Staphylococcus aureus, Proteus mirabilis, Bacteriodes were the most prevalent bacteria while Acinetobacter boumenii and Pseudomonas aeruginosa species were also causing CSOM (Table 2).
In gender wise distribution, 28 (29.78%) patients were recorded as male while 19 (20.21%) patients were recorded as Fe males. In the same manner, in Group B, 26 (27.65%) patients were recorded as Males while 21 (22.34%) were recorded as females. (Table 3).
As per efficacy of both groups is concerned, in Group A, 34 (36.17%) patients had achieved post-operative dryness on 8th week of mastoidectomy whereas in Group B, 40 (42.55%) patients achieved post-operative dryness of ear on 8th week subject to mastoidectomy with temporalis fascia flap obliteration ( p=0.130) (Table 4).
Stratification of efficacy of mastoidectomy versus mastoidectomy with temporalis fascia flap obliteration with respect to gender and age is recorded at Tables 5 and 6 respectively.
CSOM was more prevalent in children and young adults than in T able 1. Age Wise Distribution in Both Groups (N=94)
15-30-years 15 (15.95%) 15 (15.95%) 30 (31.91%) 31-45-years 15 (15.95%) 15 (15.95%) 30 (31.91%) 46-60-years 17 (18.08%) 17 (18.08%) 34 (36.17%) T otal 47 (50%) 47 (50%) 94 (100%) Group A=Patients undergoes mastoidectomy Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration.
T otal 47 (50%) 47 (50%) 94 (100%) Group A=Patients undergoes mastoidectomy Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration.
T otal p-value Group A Group B Yes 34 (36.17%) 40 (42.55%) 74 (78.72%) 0.130No 13 (13.82%) 07 (7.44%) 20 (21.27%) T otal 47 (50%) 47 (50%) 94 (100%) Group A=Patients undergoes mastoidectomy.
Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration.
Yes 21 (22.34%) 17 (18.08%) 0.978 No 06 (6.38%) 04 (4.25%)
Yes 13 (13.82%) 23 (24.46%) 0.055 No 07 (7.44%) 03 (3.19%) Group A=Patients undergoes mastoidectomy.
Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration. T able 6. Stratification of Efficacy with Age (N=94)
15-30-years Yes 11 (11.70%) 12 (12.7%) 0.665 No 04 (4.25%) 03 (3.19%) 31-45-years Yes 11 (11.70%) 13 (13.8%) 0.361 No 04 (4.25%) 02 (2.12%) 46-60-years Yes 12 (12.7%) 15 (15.95%) 0.203 No 05 (5.31%) 02 (2.12%) Group A=Patients undergoes mastoidectomy.
Group B=Patients undergoes mastoidectomy with temporalis fascia flap obliteration. T able 2. Different Microorganism Isolated from Ear Discharge Microbes Percentage Staph. aureus 35% Bacteriodes spp. 20% Proteus mirabilis 15% Peptococcus spp. 10% E. coli 5% Strep. pyogenes 3% Strep pneumonia 2% Other microorganisms 10% elders. The same study was reported by different countries like India, Africa and Pakistan.1 Allots of reasons can explain the above situation in children because the eustachain tubes in children are shorter, narrower and more horizontal than in adults.2,3 The most prevalent microbes were found in our study as shown in Table 2 Staph. aureus, Bacteriodes and Proteus mirabilis as well as other microorganisms the above finding were also shown by many clinician and researchers.20,22-24 McKenzie et al24 well-demonstrated evidence of chronic suppurative otitis in a skull found in Norfolk, UK, which is thought to be from the Anglo-Saxon period. Radiologic changes in the mastoid caused by previous infection have been seen in a number of specimens, including 417 temporal bones from South Dakota Indian burials and 15 prehistoric Iranian temporal bones.25,26 As per age distributions, the generally success rate of tympano-plasty, with or without mastoidectomy, in the management of chronic paediatric otitis media, was high and did not depend on patient age, the status of the contralateral ear, the inclusion or absence of surgical mastoidectomy, or the method of mastoidectomy.27 Our study also shows that there was no difference in age. Tympano plasty, with or without mastoidectomy, is highly effective for treatment of chronic otitis media in children.27-29 In gender wise distribution, patients undergoes mastoidectomy with temporalis fascia flap obliteration females who have comparatively better results than males for unknown reason. May be the female are more sensitive and hygenic compared with males (Table 3).
The application of for tympanoplasty has been very useful in the past in spite of the comparatively worse vibration characteristics of the rigid material. These findings are according to our own experiences with autologous cartilaginous transplant for the treatment of COSM and retraction cholesteatoma.27-29 As per efficacy of both groups is concerned, in Group A, 36.17% patients had achieved post-operative dryness on 8 th week of mastoidectomy whereas in Group B, 42.55% patients achieved post-operative dryness of ear on 8th week subject to mastoidectomy with temporalis fascia flap obliteration. The same results are also shown by other surgeons and clinicians, p=0.130.30,31 Efficacy wise the patients undergoing mastoidectomy with temporalis fascia flap obliteration were better than under going mastoidectomy for CSOM. On relating average hearing improvement post-operatively with eustachain tube function in the ears with cured flap i.e. was 50%. It was detected that in ears with normal eustachain tube function post-operative hearing increase was 55% whereas in ears with eustachain tube dysfunction post-operative hearing gain (Table 4).
Globally, there was increase awareness about the signif icant morbidity of ear discharge. The fatten recognition of the role of mastoid obliteration in success of post-operative dry ear has significant management implications. Our study has furnished valuable information in this regard and will help to improve the existing situation with a positive influence on the overall outcome of management.
Our study proved that patients who underwent mastoidectomy with temporalis fascia flap obliteration yielded better results in comparison to patients who underwent open mastoidectomy. Further the common organism were found in our region Staph Aureus and Bacteriodes and Proteus mirabilis. More studied required to further evaluate these patients in prospective study.
There is no financial support.
The authors declare that they have no conflicts of interest.