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Register:	ISRCTN
Last refreshed on:	28 November 2022
Main ID:	ISRCTN50406162
Date of registration:	23/11/2017
Prospective Registration:	Yes
Primary sponsor:	Helsinki University Hospital
Public title:	Efficacy of balloon Eustachian tuboplasty
Scientific title:	Efficacy of balloon Eustachian tuboplasty - prospective, blinded and placebo-controlled multi-centre study
Date of first enrolment:	27/11/2017
Target sample size:	165
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN50406162
Study type:	Interventional
Study design:	Prospective blinded placebo-controlled multi-centre study (Treatment)
Phase:	Not Applicable

Countries of recruitment
Finland

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Saku Sinkkonen
Address:	Kasarmikatu 11-13 00029 Helsinki Finland
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
All patients in this study suffer from dilatory Eustachian tube dysfunction and are deemed suitable for BET. Possible indications are:
1. Persistent secretory otitis media
2. Severe symptoms of ETD
3. Baro-challenged ETD

Exclusion criteria:
1. The occurrence of cleft palate in any form
2. Current ventilating grommet
3. Tympanic membrane perforation
4. Adhesive otitis
5. Cholesteatoma
6. Cystic fibrosis
7. Immotile cilia syndrome
8. Untreated nasal polyposis
9. Samter's triade
10. Untreated gastroesophageal reflux disease
11. Other mechanical obstruction in nasopharynx

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Persistent secretory otitis media, severe symptoms of ETD or baro-challenged ETD
Ear, Nose and Throat
Nonsuppurative otitis media, unspecified; other disorders of Eustachian tube

Intervention(s)

Parallel-group randomisation is made after local anaesthesia induction before the operation. Patients are treated with either BET or sham surgery under local anaesthesia. The patients are blinded to the procedure. Postoperative controls are arranged 3 and 12 months after operation in a blinded manner by a physician not given the treatment.

Primary Outcome(s)

Measured at baseline, 3 months and 1 year:
1. Valsalva maneuver based on physicians descriptive findings
2. Otomicroscopy based on physicians descriptive findings
3. Tympanometry results classified as A, B and C type outcomes
4. Tubomanometry results based on the Eustachian tube opening and opening latency index
5. Need for grommets

Secondary Outcome(s)

Quality of life measured with disease specific questionnaire ETDQ7 at baseline, 3 months and 1 year

Secondary ID(s)

§97/2017

Source(s) of Monetary Support

State funding for University level health research, Research Foundation for ENT Disorders

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Tampere University Hospital Ethics Committee, 02/05/2017, ref: R17040

Results

Results available:	Yes
Date Posted:
Date Completed:	31/05/2022
URL:

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