Objective:
The effectiveness of balloon tuboplasty in improvement of eustachian tube function in patients with eustachian tube dysfunction
Design:
clinical trial
Setting and conduct:
All patients with serous otitis media resistant to medical therapy in amiralam hospital receive balloon tuboplasty surgery
Major inclusion and Exclusion criteria:
Inclusion criteria: some patients with 18-60 years age; some patients with resistant serous otitis media; some patients with recurrence of symptoms after ventilation tube replacement.
Exclusion criteria: some patients with past history of nasopharyngeal tumor; some patients with high risk for gerenal anesthesia; some patients with history of systemic diseases.
Intervention:
Case group: in 20 patients with serous otitis media resistance to therapy after audiometric tests and endoscopy ,surgery will be done.
At first the catteter entered to cartilage eustachian tube and fill with salin with 10 bar pressur and the balloon refill after second minute and the catteter extrude.
Control group: No control group
Main outcome measures(variables):
The treatment of hearing loss
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015091524031N1
Registration date:2015-12-27, 1394/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Mojtaba Mohammadi Ardehali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
mohamadm@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of changes on function of eustachian tube after balloon tuboplasty on patients with resistant serous otitis media
Public title
Evaluation result of balloon tuboplasty on patients with serous otitis media
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-60 years old patients; patients with resistant serous otitis media; patients with recurrence of symptoms after ventilation tube replacement.
Exclusion criteria: patients with past history of nasopharyngeal tumor; patients with high risk for general anesthesia; patients with history of systemic diseases.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
1417653761
Approval date
2015-10-13, 1394/07/21
Ethics committee reference number
IR.TUMS.REC.1394.954
Health conditions studied
1
Description of health condition studied
Serous Otitis
ICD-10 code
H65.9
ICD-10 code description
Nonsuppurative otitis media, unspecified
Primary outcomes
1
Description
Recovery of eustachian tube function
Timepoint
Befor surgery and 1 week after surgery and 3 month and 6 month after surgery
Method of measurement
Valsalva maneuver and R Index and audiometry
Secondary outcomes
1
Description
Improvement in hearing
Timepoint
1 week after surgery and 3 month and 6 month after surgery
Method of measurement
Typmanometery and PTA test and ETT test
Intervention groups
1
Description
Intervention group: 20 patients with serous otitis media resistance are undergoing balloon tuboplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam Hospital
Full name of responsible person
Dr Mojtaba Mohamadi Ardehali
Street address
AmirAlam Hospital, North Saadi Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellorfor Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Central Organization of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellorfor Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Dr Mahnaz Mohammadi
Position
Otolaryngologist
Other areas of specialty/work
Street address
AmirAlam Hospital, Department of Coclear Implant
City
Tehran
Postal code
1145765111
Phone
+98 21 6670 8104
Fax
+98 21 6676 0269
Email
drmohamadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mojtaba Mohammadi Ardehali
Position
Associate Professor of Otolaryngology
Other areas of specialty/work
Street address
Department of Otorhinolaryngology, AmirAlam Hospital, Tehran
City
Tehran
Postal code
1145765111
Phone
+98 21 6670 3037
Fax
+98 21 6676 0269
Email
mmardehali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mahnaz Mohammadi
Position
Otolayngologist
Other areas of specialty/work
Street address
Department of Coclear Implant, AmirAlam Hospital, Tehran
City
Tehran
Postal code
1145765111
Phone
+98 21 6670 8104
Fax
+98 21 6676 0269
Email
drmohamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)