Determining the effectiveness of new surgical technique for concomitant treatment of nasal fracture and correction of old nasal bone deviation
Design
This study is a phase 3 quasi clinical trial with no independent control group. Nose aesthetic status and breathing will be compared before and after the intervention in patients with a history of old nasal deviation. The sample size is 30 people
Settings and conduct
The place of study ENT ward of Hamadan hospital 2019-2020
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with new nasal bone fractures with old nose bone deviation.
Ages 18-50 years for women and 18-60 years for men.
Patient satisfaction to correct old nose bone deviation
Exclusion criteria:
History of CSF leak, seizures, neurosurgery, maxillofacial surgery in the middle and upper thirds of the face,Coagulopathy, head trauma, reduced consciousness, postoperative trauma, cartilage deformity, nasal fracture, sore fractures Has been,
Intervention groups
n this study, patients with nasal fractures with a history of nasal deviation before recent trauma were enrolled. After induction of general anesthesia, first new fracture treated, then the old nasal deviation is then corrected after the nasal bone is broken.
Main outcome variables
Correction of old nasal deviation with new nasal fracture treatment, increased patient satisfaction with nasal aesthetics and improved nasal breathing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N5
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
New technique for correction of old nasal bone deviation during nasal fracture reduction
Public title
correction of old nasal bone deviation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with new nasal bone fractures with old nose bone deviation
Ages 18-50 years for women and 18-60 years for men.
Patient satisfaction to correct old nose bone deviation
Exclusion criteria:
history of CSF leak
History of seizures
History of neurosurgery, maxillofacial surgery in the middle and upper third of the face
A history of coagulopathy
Post-operative trauma history, cartilage deformity, nasal fracture
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Hamadan Univercity of Medical Science
Street address
Shahid Fahmideh َ
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.UMSHA.REC.1397.145
Health conditions studied
1
Description of health condition studied
Nose deviation
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Correction of old nasal bone deviation
Timepoint
Before inserting a new fracture, after removing the mesh and casting, three months after surgery
Method of measurement
Take a photo of the nose
Secondary outcomes
1
Description
Improve patient nasal breathing
Timepoint
Before surgery and three months after surgery
Method of measurement
with NOSE questionnaire
2
Description
Patient satisfaction of nose beauty
Timepoint
Before surgery and three months after surgery
Method of measurement
use of ROE questionnaire
Intervention groups
1
Description
Intervention group: In this study, patients with nasal fractures with a history of nasal deviation before recent trauma were enrolled. After induction of general anesthesia and oro-tracheal tube insertion, the nasal dislocation is first surgically located. To correct the old deviation, first place a two-layer 3 x 3 cm vibrile piece on the most prominent lateral part of the dorsum (to prevent skin injury) and the non-dominant thumb parallel to the eyebrow, gently and without pressure on The eye to protect the eye from accidental impact). At this point, the surgeon uses a surgical hammer with a 30 ° recoil to the horizontal line of the face and from 15 to 20 cm from the nose, simply by moving the wrist (while the arm and elbow are fixed) to strike the vibrating, The most prominent lateral part of the dorsum enters the convex side. The blows can be repeated to break the old fragment. Then according to the conventional method, if the fragment is unstable (convex or concave), a tetracycline impregnated mesh 4 to 6 cm long between the septum and the moving fragment It is placed in the direction of stability. Then the nose is stabilized by casting.After 5 to 7 days the mesh impregnated with tetracycline and casting is removed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
dr Roholla Abbasi
Street address
shahid Beheshti Blvd
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ِDr Saeid Bashirian
Street address
Shahid Fahmide
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3838 0097
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Rohollah Abbasi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shahid Beheshti Blv
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
r.abbasi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2021 onwards it is permissible
To whom data/document is available
Researchers in all fields
Under which criteria data/document could be used
To develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document