The aim of this study is comparison of rate and severity of nasal mucosal tear with internal and external lateral nasal osteotomy using endoscope.30 candidates of elective nasal surgery (10 males and 20 females)aged 20 to 30 years will be studied from April 2014 to Auguest 2014 in this trial.
Inclusion criteria:all candidates of elective nasal surgery aged 20 to 30 years.
Exclusion criteria:
1.patients with history of nasal trauma
2. patients with history of nasal surgery
3.patients with severe deformity of nasal dorsum requiring complex osteotomies
In this patients an external lateral osteotomy will be performed on one side and an internal lateral osteotomy will be performed on the alternate side.finally prevalence and severity of nasal mucosal tear will be compared between two sides and two groups.at the end of this study the technique of lateral nasal osteotomy with lower rate and severity of nasal mucosal tear will be demonstrated as the preffered technique.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061013938N2
Registration date:2014-07-20, 1393/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Mohamadali Ghavimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
ghavimim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences,investigation secretary,research center of periodontal diseases
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rate and severity of nasal mucosal tear with internal and external lateral nasal osteotomy using endoscope
Public title
effect of two different surgical techniques on amount of nasal mucosal tear
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:all candidates of elective rhinoplasty aged 20-30years
exclusion criteria:1-patients with systemic diseases 2-history of previous nasal trauma 3-uncooperative patients 4-history of previous nasal surgery 5-patients with inflammation of nasal mucosa 6-patients with severe deformity of nasal dorsum who need complex methods of osteotomy
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences/ethics committee
Street address
Daneshgah square,daneshgah avenue,Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2014-06-29, 1393/04/08
Ethics committee reference number
9352
Health conditions studied
1
Description of health condition studied
nasal mucosal tear
ICD-10 code
T81.2
ICD-10 code description
Accidental puncture and laceration during a procedure, not elsewhere classified
Primary outcomes
1
Description
amount of nasal mucosal tear
Timepoint
immediately after intervention(intraoperatively)
Method of measurement
indirect view using endoscope
Secondary outcomes
1
Description
amount of bleeding
Timepoint
immediately after completion of osteotomy
Method of measurement
measurment of blood volume (millileter)
Intervention groups
1
Description
intervention group: after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began,3mm osteotome without guard was introduced through skin at the midway between inner canthus and vestibule. when the cutting edge of osteotome reached bone the external osteotomy was initiated . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm).
Category
Treatment - Surgery
2
Description
control group: after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began. mucosal incision was made at the lateral nasal wall just above the junction of inferior turbinate.after introduction of 3mm guarded osteotome the internal osteotomy was initiated and completed at the level of the inner canthus . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial surgery clinic
Full name of responsible person
Doctor alihosein mesgarzade
Street address
Daneshgah square,danshgah avenue,Imam reza teaching centre
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigation secretary of tabriz university of medical sciences
Full name of responsible person
Doctor hassan soleimanpoor
Street address
Daneshgah avenue,investigation secretary of 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
Investigation secretary of 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/denistry faculty
Full name of responsible person
Doctor alihosein mesgarzade
Position
Maxillofacial surgery specialist/lecturer
Other areas of specialty/work
Street address
Danshgah square,daneshgah avenue,dentistry faculty,maxillofacial surgery ward
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
mesgarcu@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences,dentistry faculty,maxillofacial surgery ward
Full name of responsible person
Doctor alihosein mesgarzade
Position
Maxillofacial surgery specialist/lecturer
Other areas of specialty/work
Street address
Danshgah square,daneshgah avenue,dentistry faculty,maxillofacial surgery ward
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
mesgarcu@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz unuversity of medical sciences/dentistry faculty