Effectiveness of Surgical Approach of Insertion Ventilation Tubes (Tympanostomy) and Adenoidectomy in Comparison with Non-Surgical Approach (Watchful Waiting Approach) in Children at the Age between 1 and 6 and Who Suffer from Otitis Media with Effusion (OME) in 12-Month Period of Observation—The Retrospective Analysis

(1) Background: Otitis media with effusion (OME) is one of the most common diseases in childhood. The objective was to assess clinically the effectiveness of the surgical approach (tube insertion with adenoidectomy) in comparison with the non-surgical approach (watchful waiting) during a 12-month observation period. (2) Methods: This study was retrospective and obtained approval from the bioethics committee. The criteria of inclusion in the first group (surgical approach) were: (1) a diagnosis of chronic otitis media with effusion in children aged between 1 and 6 years; (2) their medical history showed that they had undergone adenoidectomy and tympanostomy with the insertion of ventilation tubes (VTs). The criteria for inclusion in the second group (non-surgery) were similar to the first group except that their medical history showed they had not undergone adenoidectomy or tympanostomy with the insertion of VTs. There were 422 children included in the surgical group and 50 children in the non-surgical group, and the period of observation was 12 months. (3) Results: For the entire surgical group, the number of healthy days ranged from 20 to 365, with a mean of 328.0 days (SD = 91.4).In the non-surgical group, the number of healthy days ranged from 13 to 365, with a mean of 169.2 days (SD = 127.3). The difference in the number of healthy days was statistically significant (p < 0.001). The certainty of treatment in the first group was higher than in the second group, and the number of days without recurrence was significantly higher than in the second group. In the first group, there were 71 recurrences from 422 children (16.8%), and, in the second subgroup, there were 40 recurrences of acute otitis media (AOM) from 50 children (80%). The RR was 0.21. (4) Conclusions: The surgical approach in children aged 1–6 years who have been diagnosed with otitis media with effusion is reasonable and beneficial for the child.

Role of intratympanic steroid injection in treatment of otitis media with effusion: A systematic review/ Meta -Analysis

Background Otitis media with effusion (OME) is a worldwide major health problem for both children and adult, who have a history of chronic eustachian tube dysfunction. Aim of the Work to review the effect of intratympanic injection of steroids in treatment of chronic otitis media with effusion (persistent more than 3 months after failure to medical treatment [e.g. local & systemic steroids or decongestants] or surgical ventilation tubes). Material and Methods This systematic review was done as a collective analysis of 5 retrospective and prospective cohort studies done on patients with OME. Studies on Patients who were diagnosed with chronic otitis media with effusion not responding to conventional methods of treatment. Results The data analysed and results showed an improvement of 41.2% of the cases treated with intratympanic injection of steroids compared to 11% improvement in cases treated by conventional medical methods with a relative improvement around 6.4 folds to intratympanic injection of steroids over medical treatment. All of these studies have shown that there are more advantages of directed ototopical steroid therapy over systemic therapy. Topical medications often have limited systemic effects due to their limited systemic uptake. It may be less expensive as compared to systemic medications. Conclusion Intratympanic injection of long acting steroids has good effect in management of OME resistant to medical and surgical treatment and has superior effect and high rate of recovery on local nasal steroid spray. In children combination of ventilation tubes and intratymapnic injection of steroids is the best known modality of treatment. Further studies are needed to evaluate the best medical treatment of chronic OME.

Outcomes of Mastoidectomy With Antibiotic Catheter Irrigation for Patients With Draining Ventilation Tubes

Objectives: To evaluate the effectiveness of mastoidectomy with antibiotic catheter irrigation in patients with chronic tympanostomy tube otorrhea. Methods: A chart review of adult and pediatric patients with persistent tympanostomy tube otorrhea who had failed outpatient medical management and underwent mastoidectomy with placement of a temporary indwelling catheter for antibiotic instillation was performed. Patients were retrospectively followed for recurrent drainage after 2 months and outcomes were categorized as resolution (0-1 episodes of otorrhea or otitis media with effusion during follow-up), improvement (2-3 episodes), or continued episodic (>3 episodes). Results: There were 22 patients and 23 operated ears. Median age was 46 years (interquartile range, IQR = 29-65). The median duration of otorrhea from referral was 5.5 months (IQR = 2.8-12). Following surgery, 14 ears had resolution of drainage, 6 had improvement, and 3 had episodic. The observed percentage of resolved/improved ears (87%) was significant ( P = .0005, 95% CI = 67.9%-95.5%). Median follow-up time was 25 months (IQR = 12-59). Pre and postoperative pure tone averages improved (difference of medians = −3.3 dB, P = .02) with no significant difference in word recognition scores ( P = .68). Methicillin-resistant Staphylococcus aureus was the most common isolated microbe while no growth was most frequently noted on intraoperative cultures. Conclusions: Mastoidectomy with antibiotic catheter irrigation may be an effective surgical strategy, and single stage alternative to intravenous antibiotics, for select patients with persistent tube otorrhea who have failed topical and oral antibiotics.

PREVALENCIA DE OTITIS MEDIA CON EFUSIÓN EN NIÑOS CON LABIO Y PALADAR HENDIDO.

IntroductionOtitis media with effusion (OME) is a highly prevalent problem in children with cleft lip and palate (CLP). The objective of this study was to establish the prevalence of OME in children with CLP younger than 1 year.Patients and methodsObservational and descriptive study in 19 patients younger than 1 year of age and of both genders, evaluated at the Hospital Metropolitano, from January 2017 to November 2019. The results of otoacoustic emissions and tympanometry were taken into account. The intraoperative presence of discharge in the middle ear established the certain diagnosis of OME.ResultsTwelve patients were men (63%) and 7 women (37%), 13 children (68%) were ≤6 months old, while 6 patients (32%) between 6 months and 1 year. All 19 cases were clinically diagnosed with OME, although the results of acoustic otoemissions and tympanometry were not always confirmed. At least 3 months old, they underwent myringotomy + placement of ventilation tubes. In the two age groups, all presented mucus in the middle ear confirming OME, the prevalence of cases of children under 6 months was 100%, 95% CI (77-100); in patients 6 months to 1 year it was also 100%, 95% CI (60-100).Conclusions The prevalence of OME in children younger than 1 year with CLP is 100%, a diagnosis established by the confirmed presence of a discharge in the middle ear

Ventilation tube non-function due to blockage in children: the frequency, course and effect on hearing. A prospective cohort study

Objective To assess the effect on hearing of non-functioning ventilation tubes due to blockage during the first six months post-operatively, using UK national guidelines. Method A prospective, observational study was conducted on 37 children who underwent bilateral ventilation tube insertion. Air and bone conduction thresholds were measured before and following surgery, and at one, three and six months post-operatively. Tube non-function was assessed by tympanometry supported by otoscopy. Results Post-operatively, an average of 21 per cent of ventilation tubes were non-functioning. Ears with non-functioning tubes had significantly (p = 0.0001) poorer mean air conduction thresholds than functioning tubes, with a magnitude of 6 dB HL. Ears with otorrhoea were most affected (15 per cent). At any one visit, the air–bone gap was closed to 10 dB or less in 76 per cent of ears. Non-functioning tubes reduced this to 56 per cent. Compared with tympanometry, otoscopy underdiagnosed tube non-function due to blockage by 22 per cent. Conclusion Non-functioning of ventilation tubes occurs frequently and can be missed on otoscopy. Although it is associated with poorer air conduction thresholds, the magnitude of this difference is unlikely to warrant further intervention unless there is otorrhoea or recurrence of bilateral hearing impairment.

Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study)

Background Otitis media with effusion is the major cause of acquired hearing problems in children. Some of the affected children need surgery with ventilation tubes in the tympanic membrane to reduce ear complaints and to improve hearing, middle ear function, and health-related quality of life. This is one of the most common ambulatory surgeries performed on children. Postoperative controls are needed to assess that the tubes are functional, to evaluate whether hearing loss has been improved, and to handle potential complications. The follow-up may continue for years and are usually done by otolaryngologists. Nevertheless, there exist no evidence-based guidelines concerning the level of expertise needed for postoperative controls of the ventilation tubes. The aim of this protocol is to describe the ConVenTu study that evaluates whether postoperative controls performed by general practitioners (GPs) represent a safe and sufficient alternative to controls performed by otolaryngologists. Methods/design Multicenter randomized non-inferiority study conducted in clinical settings in seven hospitals located in Norway. Discharged children with ventilation tubes, aged 3–10 years, are allocated randomly to receive postoperative controls by either an otolaryngologist at the hospital where they had ventilation tube surgery or their regular GP. Study participants are enrolled consecutively until 200 patients are included in each group. Two years after surgery, we will compare the pure tone average of hearing thresholds (primary endpoint) and middle ear function, complication rate, health-related quality of life and the parents’ evaluations of the postoperative care (secondary endpoints). Discussion This protocol describes the first randomized non-inferiority study of GPs performing postoperative controls after surgery with ventilation tubes. Results from this study may be utilized for deriving evidence-based clinical practice guidelines of the level of postoperative controls after ventilation tube surgery which is safe and sufficient. Trial registration ClinicalTrials.govNCT02831985. Registered on 13 July 2016

Otoacoustic Emissions in Children with Long-Term Middle Ear Disease

Introduction: Otoacoustic emissions (OAEs) evaluate the functional status of the cochlea. Repeated otitis media (OM) can cause changes in the peripheral structures of the auditory system, and, in this way, middle ear infection may irreversibly damage the middle ear, or even the cochlea. Objectives: To analyze the results of transiently evoked otoacoustic emissions (TEOAEs) and distortion product otoacoustic emissions (DPOAEs) in individuals with a history of OM. Method: Participants with 8 to 16 years of schooling were split into two groups: a control group (CG) of 50 subjects who had no history of otological disease and an experimental group (EG) of 50 subjects who had a history of recurrent otitis in childhood and had consequently undergone myringotomy to insert bilateral ventilation tubes. All children underwent basic audiological assessment (tonal audiometry, speech audiometry, and immittance testing) and otoacoustic emission testing (TEOAEs and DPOAEs). Results: There were no significant differences between the groups when audiometrically tested via air and bone conduction. OAEs were found in all CG subjects. For the EG, there were no TEOAE responses in 17 ears and no DPOAEs in nine ears; response amplitudes were lower at all frequencies. The emission level and the signal-to-noise ratio were statistically different between the two groups, and OAEs in the EG were statistically smaller compared to the GC. Conclusion: In the EG, responses were more likely to be absent and were of statistically smaller amplitude compared to the CG. A history of repeated OM apparently interferes with the generation and transmission of TEOAEs and DPOAEs.

Postoperative Controls of ventilation tubes in children - by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study)

Background: Otitis media with effusion is the major cause of acquired hearing problems in children. Some of the affected children need surgery with ventilation tubes in the tympanic membrane to reduce ear complaints and to improve hearing, middle ear function and health-related quality of life. This is one of the most common ambulatory surgeries performed on children. Postoperative controls are needed to assess that the tubes are functional, evaluate whether hearing loss has been improved, and to handle potential complications. The follow-up may continue for years and are usually done by otolaryngologists. Nevertheless: there exist no evidence-based guidelines concerning the level of expertise needed for postoperative controls of the ventilation tubes. The aim of this protocol is to describe the ConVenTu study that evaluates whether postoperative controls performed by general practitioners (GPs), represent a safe and sufficient alternative to controls performed by otolaryngologists. Methods/design: Multicenter randomized non-inferiority study conducted in clinical settings in seven hospitals located in Norway. Discharged children with ventilation tubes, aged 3-10 years are allocated randomly to receive postoperative controls by either an otolaryngologist at the hospital where they had ventilation tube surgery or their regular GP. Study participants are enrolled consecutively until 200 patients are included in each group. Two years after surgery we will compare pure tone average of hearing thresholds (primary endpoint) and middle ear function, complication rate, health-related quality of life and the parents’ evaluations of the postoperative care (secondary endpoints). Discussion: This protocol describes the first randomized non-inferiority study of GPs performing postoperative controls after surgery with ventilation tubes. Results from this study may be utilized for deriving evidence-based clinical practice guidelines of the level of postoperative controls after ventilation tube surgery which is safe and sufficient.

Postoperative Controls of ventilation tubes in children - by general practitioner or otolaryngologist? Study protocol for a prospective, multicenter, randomized study (The ConVenTu study)

Background: Insertion of ventilation tubes (VTs) in the tympanic membrane is one of the most common ambulatory surgeries performed on children. Postoperative care may continue for two or more years and is today mostly done by otolaryngologists. Postoperative care given by general practitioners (GPs) may represent a sufficient level of health care regarding clinical outcome, but there exist no evidence-based guidelines concerning the level of expertise for this task. The aim of this study is to evaluate whether postoperative care after surgery with VTs performed by GPs represent a sufficient alternative to otolaryngologists.Methods/design: Prospective study of postoperative care after surgery with VTs in children aged 3-10 years. At discharge, each patient is allocated randomly to postoperative care by either otolaryngologist or their regular GP. Study participants are enrolled consecutively from seven different hospitals in Norway until 200 patients are included in each study group. Hearing thresholds, middle ear function, complication rate, health related quality of life and the guardians’ experiences two years after surgery, will be compared. Discussion: Results from the ConVenTu study are expected to contribute with knowledge regarding optimal postoperative care after surgery with VTs.