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A Prospective, Randomized, Controlled Clinical Study of BET Combined With Tympanostomy Tube Insertion in the Treatment of Intractable OME After Radiotherapy for NPC

NCT05449184 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-07-08

No results posted yet for this study

Summary

The primary purpose of this study is to compare balloon Eustachian tuboplasty (BET) combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of otitis media with effusion (OME) in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram.

The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.

Conditions

  • Otitis Media With Effusion After Nasopharyngeal Carcinoma

Interventions

PROCEDURE

Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion

Under local or general anesthesia, insert a balloon into one Eaustachian tube and inflate it for up to two minutes. The balloon is then removed. Subsequently, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later.

PROCEDURE

Tympanostomy Tube Insertion

Under local or general anesthesia, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Hao Xiong · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449184 on ClinicalTrials.gov