Dataset Information

Factors Affecting the Extrusion Rate and Complications After Ventilation Tube Insertion: A Multicenter Registry Study on the Effectiveness of Ventilation Tube Insertion in Pediatric Patients With Chronic Otitis Media With Effusion-Part II.

ABSTRACT:

Objectives

The impacts of ventilation tube (VT) type and effusion composition on the VT extrusion rate and complications in children with otitis media remain unclear. This part II study evaluated the factors affecting the extrusion rate, recurrence rate, and complications of VT insertion.

Methods

A prospective study was conducted between June 2014 and December 2016 (the EVENT study [analysis of the effectiveness of ventilation tube insertion in pediatric patients with chronic otitis media]), with follow-up data collected until the end of 2017. Patients aged <15 years diagnosed with otitis media with effusion who received VT insertion were recruited at 15 tertiary hospitals. The primary outcomes were time to extrusion of VT, time to effusion recurrence, and complications.

Results

Data from 401 patients were analyzed. After excluding the.

Results

of long-lasting tubes (Paparella type II and T-tubes), silicone tubes (Paparella type I) exhibited a significantly longer extended time to extrusion (mean, 400 days) than titanium tubes (collar-button-type 1.0 mm: mean, 312 days; P<0.001). VT material (hazard ratio [HR], 2.117, 95% confidence interval [CI], 1.254-3.572; P=0.005), age (HR, 3.949; 95% CI, 1.239-12.590; P=0.02), and effusion composition (P=0.005) were significantly associated with the time to recurrence of middle ear effusion. Ears with purulent (mean, 567 days) and glue-like (mean, 588 days) effusions exhibited a shorter time to recurrence than ears with serous (mean, 846 days) or mucoid (mean, 925 days) effusions. The revision VT rates during follow-up were 3.5%, 15.5%, 10.4%, and 38.9% in ears with serous, mucoid, glue-like, and purulent effusions, respectively (P<0.001). The revision surgery rates were higher among patients aged <7 years than among those aged ≥7 years.

Conclusion

Silicone tubes (Paparella type I) were less prone to early extrusion than titanium 1.0 mm tubes. VT type, patient age, and effusion composition affected the time to recurrence of effusion.

SUBMITTER: Yoo MH

PROVIDER: S-EPMC9723292 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Factors Affecting the Extrusion Rate and Complications After Ventilation Tube Insertion: A Multicenter Registry Study on the Effectiveness of Ventilation Tube Insertion in Pediatric Patients With Chronic Otitis Media With Effusion-Part II.

Yoo Myung Hoon MH Cho Yang-Sun YS Choi June J Choung Yun Hoon YH Chung Jae-Ho JH Chung Jong Woo JW Han Gyu Cheol GC Jun Beom Cho BC Kim Dong-Kee DK Kim Kyu Sung KS Lee Jun Ho JH Lee Kyu-Yup KY Lee Seung Hwan SH Moon In Seok IS Park Hong Ju HJ Park Shi Nae SN Rhee Jihye J Seo Jae Hyun JH Yeo Seung Geun SG

Clinical and experimental otorhinolaryngology 20220901 4

<h4>Objectives</h4>The impacts of ventilation tube (VT) type and effusion composition on the VT extrusion rate and complications in children with otitis media remain unclear. This part II study evaluated the factors affecting the extrusion rate, recurrence rate, and complications of VT insertion.<h4>Methods</h4>A prospective study was conducted between June 2014 and December 2016 (the EVENT study [analysis of the effectiveness of ventilation tube insertion in pediatric patients with chronic otit ...[more]

PMID: 36097840

Similar Datasets

Project description:BackgroundThe surgical insertion of Ventilation Tubes (VTs) for the management of persistent bilateral Otitis Media with Effusion (OME) in children remains a contentious issue due to the varying opinions regarding the risks and benefits of this procedure. The aim of this study was to evaluate the economic impact of VTs insertion for the management of persistent bilateral OME in children, providing an additional perspective on the management of one of the commonest medical conditions of childhood.MethodsA decision-tree model was constructed to assess the cost-effectiveness of VTs strategy compared with the Hearing Aids (HAs) alone and HAs plus VTs strategies. The model used data from published sources, and assumed a 2-year time horizon and UK NHS perspective for costs. Outcomes were computed as Quality-Adjusted Life-Years (QALYs) by attaching a utility value to the total potential gains in Hearing Level in decibels (dBHL) over 12 and 24 months. Modelling uncertainty in the specification of decision-tree probabilities and QALYs was performed through Monte Carlo simulation. Expected Value of Perfect Information (EVPI) and partial EVPI (EVPPI) analyses were conducted to estimate the potential value of future research and uncertainty associated with the key parameters.ResultsThe VTs strategy was more effective and less costly when compared with the HAs plus VTs strategy, while the incremental cost-effectiveness ratio for the VTs strategy compared with the HAs strategy was £ 5,086 per QALY gained. At the willingness-to-pay threshold of £ 20,000 per QALY, the probability that the VTs strategy is likely to be more cost-effective was 0.58. The EVPI value at population level of around £ 9.5 million at the willingness-to-pay threshold of £ 20,000 indicated that future research in this area is potentially worthwhile, while the EVPPI analysis indicated considerable uncertainty surrounding the parameters used for computing the QALYs for which more precise estimates would be most valuable.ConclusionsThe VTs strategy is a cost-effective option when compared with the HAs alone and HAs plus VTs strategies, but the need for additional information from future study is evident to inform this surgical treatment choice. Future studies of surgical and non-surgical treatment of OME in childhood should evaluate the economic impact of pertinent interventions to provide greater context.

Project description:BackgroundOtitis 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 analysisThis 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).DiscussionThis 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 registrationChinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

Project description:ObjectiveIdentify the risk factors for otitis media with effusion (OME), especially laryngopharyngeal reflux (LPR), adenoid hypertrophy and allergic rhinitis, that could be used to develop prevention strategies in children.DesignA comparative cross-sectional study was conducted to make sure the adequacy of proportions of OME and non-OME cases in finding the related factors.SettingHistory taking, ear/nose/throat (ENT) examination, and tympanometry were performed in preschool and elementary schools. Flexible fibreoptic nasopharyngolaryngoscopy was performed in a bronchoesophagology outpatient clinic in a tertiary referral hospital in Jakarta, Indonesia.ParticipantsPreschool and elementary children in East Jakarta, Indonesia were recruited for this study. A total of 2016 participants underwent history taking, ENT examination and tympanometry. The case group was 46 children with OME, and the control group was 46 children without OME. The number of subjects fulfilled the minimum sample size for two proportions comparison.Main outcome measuresA type B tympanogram indicated OME. A Reflux Finding Score of more than 7 indicated LPR. Adenoid hypertrophy was diagnosed using flexible fibreoptic nasopharyngolaryngoscopy. Allergic rhinitis was diagnosed using a questionnaire based on the International Study of Asthma and Allergies in Childhood phase III that has been validated for Indonesians.ResultsThe proportion of LPR in the OME group was significantly higher than in the non-OME group, at 78.3% and 52.2%. The probability of OME occurrence in patients with LPR was 3.3 times higher than in patients without LPR (OR 3.3; 95% CI 1.33 to 8.189; p=0.01). There was no significant relationship between adenoid hypertrophy and OME (p=0.211; 95% CI 0.71 to 3.97), and also between allergic rhinitis and OME (p=0.463; 95% CI 0.61 to 4.28).ConclusionThe probability of OME occurrence in patients with LPR was 3.3 times higher than in patients without LPR. LPR should be considered in patients with OME and vice versa.

Dataset Information

Factors Affecting the Extrusion Rate and Complications After Ventilation Tube Insertion: A Multicenter Registry Study on the Effectiveness of Ventilation Tube Insertion in Pediatric Patients With Chronic Otitis Media With Effusion-Part II.

Objectives

Methods

Results

Results

Conclusion

Publications

Factors Affecting the Extrusion Rate and Complications After Ventilation Tube Insertion: A Multicenter Registry Study on the Effectiveness of Ventilation Tube Insertion in Pediatric Patients With Chronic Otitis Media With Effusion-Part II.

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