The aim of this study is to compare septal deviation correction and patient's satisfaction between two groups of septoplasty with and without graft
Design
This study will conducted on totally 40 patients in two groups of intervention and control using block randomization and double blinded methods.
Concealment will carried out using pocket concealment.
Settings and conduct
The study will conducted in Dey Limited Surgery Center affiliated to Arak University of Medical Sciences. Routine treatments before and after surgery were the same for two groups and only the details of the surgery technique is different between groups. The patient and outcome assessor are blinded regarding the group f intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nasal septum deviation, patient's satisfaction for participation, age between 18-50 years;
Exclusion criteria: Drug allergies, respiratory diseases
Intervention groups
Intervention group: The surgical procedure performed under general anesthesia and one or more batten grafts made of septal cartilage is interposed between the cut ends of the caudal L-strut and then sutured. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty. Control group: The surgical procedure performed under general anesthesia and deviated septum is interposed only using swing door technique without graft. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.
Main outcome variables
Nasal septum deviation; Patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033094N3
Registration date:2021-11-11, 1400/08/20
Registration timing:retrospective
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
Mehdi Heidarizade
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6104
Email address
heidarizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-01, 1400/02/11
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The correction of nasal septal deviations in rhinoplasty: a novel approach using swing door technique with and without cartilage graft
Public title
Cartilage graft for correction of nasal septum deviation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nasal septum deviation
Patient's satisfaction for participation
Age between 18-50 years
Exclusion criteria:
Drug allergies
Respiratory diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups using the block randomization method with the following sequences: AABB, ABAB, ABBA, BAAB, and BABA. Group A undergoes the swing door without cartilage graft, and group B swing door with cartilage graft.
Concealment will carried out using pocket concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will blind about the group of intervention. Due to the finding assessment will performed after surgery and the method applied is not detectable after surgery hence outcome assessor is automatically blinded regarding the group f intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
Research and Technology Deputy of Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.ARAKMU.REC.1400.045
Health conditions studied
1
Description of health condition studied
Deviated nasal septum
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Nasal septum deviation
Timepoint
1 month after surgery
Method of measurement
Vertical perpendicular line on line connecting pupils
2
Description
Patient's satisfaction
Timepoint
1 month after surgery
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
Not applicable
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The surgical procedure performed under general anesthesia and one or more batten grafts made of septal cartilage is interposed between the cut ends of the caudal L-strut and then sutured. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.
Category
Treatment - Surgery
2
Description
Control group: The surgical procedure performed under general anesthesia and deviated septum is interposed only using swing door technique without graft. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dey Limited Surgery Center
Full name of responsible person
Mehdi Heidarizade
Street address
In front of the Department of Transfusion Medicine, Pharmacy upper floor Bu Ali, Street Shahid Shiroodi (Khoram), Arak, Iran.
City
Arak
Province
Markazi
Postal code
3919693345
Phone
+98 86 3312 7175
Fax
+98 86 3313 3147
Email
info@dsca.ir
Web page address
http://www.deylimitedsurgerycenter.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.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
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizade
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizadeh
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
ِDentistry Faculty, Arak University of Medical SciencesA'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizade
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Dentistry Faculty, Arak University of Medical SciencesA'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD