Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery in patients with chronic otitis media at valiasr and Baqiyatallah Hospital in 1392-1393
To evaluate the effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery in patients with chronic otitis media at valiasr and Baqiyatallah Hospital in 1392-1393
Design
Phase 3, randomized control clinical trial with parallel group that performed on 80 patients. Randomization was done using random number table.
Settings and conduct
All patients had surgery by three expert surgeuon in Valiasr and Baqiyatallah hospital
Participants/Inclusion and exclusion criteria
Patients with chroim otitis media came to Valiasr and Bagiyatallah hospital who had undertaken tympanoplasty and tympanomastoidectomy at Valiasr hospital.
in the case of immune deficiency due to diabetes, HIV, oral corticosteroid use, History of cholesteatoma, Patient rejection and History of previous ear surgery, patients excluded.
Intervention groups
in the intervention group, after removal of dressing, patients received ciprofloxacin eye drop 0.3% 3 to 4 times a day and betamethasone eye drop 0.1% 3 to 4 times a day for a week. patients inthe control group received no drops.
Main outcome variables
Otorrhea, graft success, otitis externa, itching.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048241N1
Registration date:2020-08-10, 1399/05/20
Registration timing:retrospective
Last update:2020-08-10, 1399/05/20
Update count:1
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Saman Rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 6182
Email address
s-rezaeian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-03, 1393/12/12
Actual recruitment start date
2013-03-21, 1392/01/01
Actual recruitment end date
2015-03-03, 1393/12/12
Trial completion date
2015-03-03, 1393/12/12
Scientific title
Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery in patients with chronic otitis media at valiasr and Baqiyatallah Hospital in 1392-1393
Public title
Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic otitis media
indication for surgery
patient preference
Exclusion criteria:
Patients with immune deficiency due to diabetes, HIV, oral corticosteroid use
History of cholesteatoma
Patient rejection
History of previous ear surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method using a table of random numbers used.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain even numbers for intervention group receiving topical drops and odd numbers for control group.Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
86100023
Health conditions studied
1
Description of health condition studied
Chronic otitis media
ICD-10 code
H66.3
ICD-10 code description
Other chronic suppurative otitis media
Primary outcomes
1
Description
Otorrhea due to graft failure
Timepoint
Week 6 and week 12 after surgery
Method of measurement
Examination by microscope
2
Description
Tympanic membrane graft success
Timepoint
Week 6 and week 12 after surgery
Method of measurement
Examination by microscope
3
Description
Post surgery otitis externa
Timepoint
Week 6 and week 12 after surgery
Method of measurement
Examination by microscope
4
Description
Post surgery itching
Timepoint
Week 6 and week 12 after surgery
Method of measurement
Examination by microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after removal of dressing, patients received ciprofloxacin eye drop 0.3% 3 to 4 times a day and betamethasone eye drop 0.1% 3 to 4 times a day for a week.
Category
Treatment - Drugs
2
Description
Control group: In patients in this group, no topical drops, prescribes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Saman Rezaeian
Street address
Mulla Sadra Street. Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
s-rezaeian@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Saman Rezaeian
Street address
Dr Gharib St. Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
MS Research Center, Sina Hospital, Hasan Abad Square- Emam Khomeyni Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
sahraian1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Rezaeian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.10, Asia Building, Ghadiri Alley, Sandough adalat Ave.
City
Rasht
Province
Guilan
Postal code
4138646867
Phone
+98 13 3336 6182
Fax
Email
s-rezaeian@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Rezaeian
Position
Otology fellowship
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Sa`adi St. Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Fax
+98 21 6670 8103
Email
s-rezaeian@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Rezaeian
Position
Otology fellowship
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Sa`adi St. Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Fax
+98 21 6670 8103
Email
s-rezaeian@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available