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Appropriate treatment of acute uncomplicated otorrhea in children with tympanostomy tubes is unclear. In this trial involving 230 children in the Netherlands, antibiotic–glucocorticoid eardrops were superior to oral amoxicillin–clavulanate or initial observation. The insertion of tympanostomy tubes is one of the most frequently performed surgical procedures in children. 1 The main indications for this procedure are the restoration of hearing in children with persistent otitis media with effusion and the prevention of recurrences in children who have recurrent acute otitis media. 2 Acute otorrhea is a common sequela in children with tympanostomy tubes, with reported incidence rates ranging from 26% in a meta-analysis of mainly observational studies (involving cases of clinically manifested otorrhea) to 75% in a randomized trial (which included asymptomatic and subclinical cases). 3 – 5 Acute tympanostomy-tube otorrhea may be accompanied by foul . . .

Background Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. Methods and analysis This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). Discussion This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial’s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. Trial registration Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

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.gov NCT02831985 . Registered on 13 July 2016

The authors report long-term follow-up of otherwise healthy young children with persistent middle-ear effusion who received either prompt insertion of tympanostomy tubes or delayed insertion if effusion persisted, as part of a randomized clinical trial or a separate observational cohort study. Prompt insertion of tympanostomy tubes did not improve developmental outcomes at 9 to 11 years of age — findings that were consistent with the results up to the age of 6 years. These findings provide additional support for a strategy of watchful waiting for children who have persistent middle-ear effusion. Prompt insertion of tympanostomy tubes did not improve developmental outcomes at 9 to 11 years of age — findings that were consistent with the results up to the age of 6 years. During the past four decades, investigators have reported that conductive hearing loss associated with persistent otitis media in young children can result in long-term impairment of their development. 1 , 2 To prevent or minimize developmental impairment, official guidelines have until recently recommended that young children in whom middle-ear effusion has persisted for as long as 3 months 3 or 4 months 4 undergo myringotomy with insertion of tympanostomy tubes in order to clear the effusion and restore hearing acuity to a normal level. In 1991, because evidence regarding the developmental effects of otitis media early in life was inconclusive, 2 and because of the . . .

Objective To prospectively evaluate the effect of tympanostomy tubes combined with adenoidectomy and tube insertion on treatment for otitis media with effusion in young children, and to analyze the related factors of prognosis and recurrence of the disease. Methods The clinical and follow-up data of 184 children with otitis media with effusion who were treated in the department of Otolaryngology, Head and Neck Surgery, Beijing Children’s Hospital, Capital Medical University from September 2013 to January 2015, were reviewed systematically. According to different surgical methods, they were randomly divided into the observation group in which patients were treated with tube insertion combined with adenoidectomy, and control group in which the rest underwent simple tube insertion. The curative effect, changes of air conduction hearing threshold before and after surgery, the healing time of tympanic membrane and recurrence of middle ear effusion were compared between the two groups. Influencing factors of recurrence of otitis media with effusion were analyzed, and the effect of healing time on tympanic membrane after tube removal was observed. Results The total effective rate of treatment in the observation group was higher than that in the control group (91.84% vs 80.23%, P  < 0.05), and the air conduction hearing thresholds in two groups were decreased significantly at 3 months and 6 months after surgery, respectively ( P  < 0.05). The total effective rate of children under 4 years old in the observation group was also higher than that in the control group. The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group ( P  < 0.05). Analysis showed that recurrent respiratory tract infection before surgery and retention time of ventilating tube shorter than 12 months were risk factors for recurrence of otitis media with effusion, while adenoidectomy was a protective factor. Besides, the tympanic membrane healing time of the tympanic membrane tube for 1 years was shorter than that of the tympanic membrane tube for more than one year ( P  < 0.05). The persisted perforation rate is 3.57% in less 12 months of tube, as opposed to it was 12% in more 12 months of tube ( P  < 0.05). Conclusions Tube insertion combined with adenoidectomy is more effective than tympanostomy tubes in the treatment of young children with OME, and the same results were found for children under four years of age. It can significantly shorten the duration of middle ear effusion and reduce the recurrence rate after surgery. For 3–6 year-old children, the upper respiratory tract infection and short ventilation tube indwelling time increase the possibility of OME recurrence, it is recommended that the ventilation tube should be retained for at least 12 months.

OBJECTIVES: The adenoid pad, which is located between the orifice of the Eustachian tube (ET) and posterior nasal cavity, can affect the development of otitis media with effusion (OME) because of its anatomical location. The aim of the present study was to evaluate adenoid microbial colonization through 16S ribosomal RNA (rRNA) pyrosequencing, an advanced molecular technique, and to document the relationship with OME. MATERIALS and METHODS: Adenoid samples were collected using sterile cotton from 32 children during ventilation tube insertion. Sixteen children with OME who underwent tonsillectomy and adenoidectomy due to obstructive symptoms were assigned to the OME group and sixteen children without OME were assigned to the control group. We performed a 16S rRNA-based culture-independent survey of bacterial communities using the MiSeq platform. RESULTS: The diversity index, mean operational taxonomic units, and Shannon index were lower in the OME group than those in the control group. A taxonomic analysis showed differences in microbiota distribution between the OME and control groups at the phylum, genus, and species levels. The analysis, which was based on weighted UniFrac distances, revealed differences in microbial composition between the two groups. CONCLUSION: Bacterial community analysis using 16S rRNA pyrosequencing allows us to understand the relationship between the microbial communities of adenoids and the development of OME better. KEYWORDS: Otitis media, microbiome, adenoid

To compare the effectiveness of myringotomy and ventilation tube insertion versus observation in post-radiation otitis media with effusion (OME) in nasopharyngeal carcinoma (NPC). NPC patients who finished radiotherapy and had persistent OME were randomized to myringotomy and ventilation tube insertion and observation groups. The resolution rate of OME and hearing outcomes were evaluated. Forty three patients (23 in control group and 20 in intervention group) were analyzed. One patient in the control group obtained a resolution of OME. The remaining patients in the control group had persistent middle ear fluid. Fourteen patients in the intervention group had retained ventilation tubes without otorrhea. Ventilation tubes had spontaneously extruded in the remaining six patients and all of these patients had recurrent OME. Mean air-pure tone average in the control group was 52.04 dB (SD 11.61), significantly different from the intervention group [38.15 dB (SD 19.10); p  = 0.01]. Mean air-bone gap in the control and intervention groups were 27.30 dB (SD 9.11) and 9.30 dB (SD 9.59) respectively ( p  < 0.001). Mean air-pure tone average and mean air-bone gap improvement was significantly improved in the intervention group ( p  < 0.001). Two patients in the intervention group (10%) developed complications, one patient suffering suppurative otitis media whilst another had otorrhea, which resolved after 1-week course of antibiotic treatment. Post-radiation OME is common in patients with NPC and tends to persist long-term. Conservative management is safe, however, is plagued by frustrating effects of hearing impairment and aural fullness. Myringotomy with ventilation tube insertion leads to hearing improvement with few complications.

Cleft lip and palate (CLP) is one of the most common congenital anomalies, affecting ~1 in 700 births worldwide. Patients with CLP often experience functional impairments due to the cleft palate, particularly related to feeding and speech. Surgical interventions are essential for addressing these issues, yet no standardized surgical procedure exists. Velar adhesion (VA) is a technique used to reduce the cleft width prior to a palatoplasty, potentially improving surgical outcomes, but its effectiveness remains unclear. The impact of VA on cleft-width reduction and the incidence of otitis media with effusion (OME) were evaluated in patients with unilateral cleft lip and palate (UCLP). The cases of 45 patients with UCLP who underwent a palatoplasty at the University of Tokyo Hospital between January 2013 and December 2023 were analyzed retrospectively. We divided the patients into two groups: those who underwent VA during lip repair (VA group) and those who did not (non-VA group). The cleft width and alveolar cleft width were measured at birth, lip repair, and palatoplasty. The presence of OME was assessed the day before the palatoplasty. Pearson's chi-square test and the two-tailed t-test were applied. Significant cleft-width reduction was observed in the VA group compared to the non-VA group at the time of palatoplasty (4.58 mm vs. 6.55 mm, p < 0.01). The incidence of OME was significantly lower in the VA group (60.00%) versus the non-VA group (90.91%, p < 0.01). No significant between-group differences were identified for the alveolar cleft width or maxillary growth. VA significantly reduces the cleft width at the junction of the hard and soft palates, and it may decrease the incidence of otitis media with effusion in patients with UCLP. VA is a straightforward procedure with potential benefits for improving palatoplasty outcomes and mitigating complications such as OME.

Background The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. Methods The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9–36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations. Discussion This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging. Trial registration ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.

Myringotomy with the insertion of ventilation tubes is the most frequent surgical procedure performed in children, and the appearance of myringosclerosis is one of its most frequent long-term complications. The objective of this study is to identify clinical factors and technique variations that may have a relation with the appearance of myringosclerosis, after tube insertion. Patients submitted to myringotomy with transtympanic short-term tube insertion were studied in a longitudinal prospective and analytical cohort study with the prospective randomized open, blinded endpoint (PROBE) methodology, to study the influence of the location of myringotomy (anterior–inferior quadrant or posterior–inferior), directions of the incision (radial or non-radial) and aspiration or not of the middle ear. Our study included 156 patients (297 ears). Myringosclerosis was observed in 35.7 % of the operated ears. It appeared more often in patients with greater number of otitis ( p  = .001) and with greater number of otorrhea episodes ( p  = .029) and in patients in whom the tympanogram after the tube extraction was type A (according to Jerger´s classification) ( p  = 0.016). We identified myringosclerosis in less patients, if the tube was in the tympanic membrane for less than 12 months ( p  = .009). Myringosclerosis was present more extensively if the tympanic incision was located in the anterior–inferior quadrant, with tympanic involvement superior to 25 % ( p  = .015). The results observed prove that, underlying the appearance of myringosclerosis, there exists an early inflammatory or infectious process and a final cicatricial process. It was also found that when myringotomy is made in the anterior–inferior quadrant, myringosclerosis appears in a higher percentage of the tympanic membrane; therefore, it is not recommended to do the incision in this quadrant, because it may lead to a reduction of the tympanic membrane vibration.