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Active, Not Recruiting

NCT Number: NCT06523933

Distribution of Bacteria in OME After Radiotherapy For NPC.

To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
  • patients volunteered to participate in the study and signed the informed consent

Exclusion criteria

  • NPC recurrence or other malignant tumor after radiotherapy.
  • clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
  • pregnant and lactating women.
  • patients with severe underlying diseases or with severe liver and kidney dysfunction.
  • patients who could not cooperate (including poor hearing and radiation encephalopathy)
  • patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
  • severe deglutition disorders
  • cleft palate

Treatment and study plan

Primary outcomes

  1. Positive Bacterial Culture Rate in Middle Ear Effusion

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Changes in Air Pressure (Tympanogram)

    Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis

    Tympanogram changed from type B to type A or type C.

  2. Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

    Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis

    The ETDQ-7 tool is used to assess the symptoms of Otitis Media With Effusion (OME), which consists of seven items with a scale of graduated responses ranging from 1 (No Problem) to 7 (Severe Problem), and 4 would correspond to a Moderate Problem. If the total score is more than 14, it is considered that there is eustachian tube dysfunction. The average post-operative ETDQ-7 score is less than 2.1 or decrease > 0.5 (minimal clinically important difference=0.5), it is considered that the eustachian tube function is improved.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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