in this clinical trial study with the intention to treat goal, 48 candidates of septoplasty surgery that hospitalized in Tabriz Imam Reza hospital in the first half of 2017 will enroll. all enrolled patients will fill the informed contest. The necessary measures for illiterate patients are also considered. patients will divide into experimental and control groups and will match in terms of age, sex and severity of the disease.
Suturing will be used in the intervention group instead of nasal splint that will be used in the control group as routine surgical procedures. The two groups will comparison in terms of postoperative pain, hematoma formation, septum perforation or nasal obstruction after 2 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021832645N1
Registration date:2017-03-01, 1395/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Shahram Gasembaglou
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 33355921
Email address
ghasembagloush@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
All financial costs arising from this study is the responsibility of the researcher
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of complications of septoplasty with and without nasal splint
Public title
Evaluating the need of nasal splint in septoplasty surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:
1-consent to participate in the study
2-septoplasty candidates
exclusion:
1-Lack of consent to participate in the study
2-Patients which need additional surgeries while undergoing septoplasty surgery
3-Patients that won't cooperate during follow-up period
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Tabriz University of medical sciences
Street address
Daneshgah St., Tabriz University of medical sciences
City
Tabriz
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
ir.tbz.med.rec.1395.11.28
Health conditions studied
1
Description of health condition studied
septoplasty
ICD-10 code
J34.2
ICD-10 code description
Deflection or deviation of septum (nasal)(acquired)
Primary outcomes
1
Description
Complications
Timepoint
2 weeks after intervention
Method of measurement
clinical examination
Secondary outcomes
1
Description
pain severity assessmnet
Timepoint
2 weeks after intervention
Method of measurement
visual pain scale
Intervention groups
1
Description
intervention: Not using splint after septoplasty
Category
Treatment - Surgery
2
Description
control: using splint after septoplasty
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
research deputy of Tabriz university of medical sciences
Street address
Daneshgah st., Tabriz university of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of medical sciences
Full name of responsible person
Reza Bahman
Position
medical student
Other areas of specialty/work
Street address
nezami st, aftab tower
City
Tabriz
Postal code
Phone
+98 41 3336 1184
Fax
Email
mr_bahman@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Shahram Gasembaglou
Position
proffessor- medical specialty degree in ENT
Other areas of specialty/work
Street address
Daneshgah st., Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
ghasembagloush@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)