(1) Objectives: The purpose of this article is to compare the outcomes and complications between external and internal lateral nasal osteotomy.
(2) Design: Grade of edema and ecchymosis according to the designed model, asymmetry and step-off deformity by direct vision and presence of bony spore by touch; will be compared between the two groups.
(3) Setting and conduct: 48 patients will be included in this study. The patients will be divided to two equal groups: internal osteotomy group (n=24) and external osteotomy group (n=24). Edema and ecchymosis 24 hours and 2, 7, and 10 days after surgery (according to the designed model ), asymmetry and step-off deformity 1 month after surgery (with direct vision), and bony spore 1 month after surgery (with touch) will be compared between the two groups.
(4) Participants including major eligibility criteria: Inclusion criteria: systematically healthy patients (ASA I & II) ؛ primary rhinoplasty patients and not revision؛ patients without significant problems in nasal structure such as thick skin؛ septal deviation؛ septal perforation؛ and trauma. Exclusion criteria: patients who do not accept to sign written informed consents؛ patient who do not attend for follow-up visits.
(5) Intervention: For 24 patients nasal osteotomy will be performed externally and for 24 patients will be performed internally.
(6) Main outcome measures (variables): edema, ecchymosis, asymmetry, step-off deformity, bony spore
General information
Acronym
not applicable
IRCT registration information
IRCT registration number:IRCT2014040717164N1
Registration date:2014-04-30, 1393/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Payam Varedi
Name of organization / entity
Faculty of dentistry, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 3251
Email address
payam.varedi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-01-13, 1392/10/23
Expected recruitment end date
2014-02-12, 1392/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Internal versus External Lateral Nasal Osteotomy in Primary Open Rhinoplasty: Comparison of Outcomes and Complications
Public title
Internal versus External Lateral Nasal Osteotomy in Primary Open Rhinoplasty: Comparison of Outcomes and Complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: systematically healthy patients (ASA I & II)؛ without disorders such as hypertension؛ diabetics؛ liver disease؛ renal disease؛ asthma؛ GI dysfunction؛ and without history of usage of anticoagulant drugs؛ anti-hypertension drugs؛ alcohol and smoke؛ patients candidate for primary rhinoplasty ؛ patients without significant problems in nasal structure such as thick skin؛ septal deviation؛ septal perforation and trauma.
Exclusion criteria: patients who do not accept to sign written consents form؛ patient who do not attend for follow-up visits.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
1
Registry name
N/A
Secondary trial Id
N/A
Registration date
empty
2
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods avenue, Keshavarz bolivar, Tehran
City
Tehran
Postal code
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
9121250001
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
asymmetry
Timepoint
1 month after surgery
Method of measurement
will be evaluated with direct vision
2
Description
step-off deformity
Timepoint
1 month after surgery
Method of measurement
will be evaluated with direct vision
3
Description
bony spore
Timepoint
1 month after surgery
Method of measurement
will be evaluated with touch
4
Description
edema
Timepoint
24 hours and 2, 7, and 10 days after surgery
Method of measurement
according to the designed model, which is available in the questionnaire
5
Description
ecchymosis
Timepoint
24 hours and 2, 7, and 10 days after surgery
Method of measurement
according to the designed model, which is available in the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In external osteotomy group, after performing a stab incision beside the piriform aperture, the 2-mm osteotome will be pushed through the soft tissue and the osteotomy will be carry out in a dotted manner.
Category
Treatment - Surgery
2
Description
In internal group after performing the incision in the nasal mucosa, the guarded osteotome will be pushed through the mucosa and osteotomy will carry out in a continuous manner.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Gandi Day Care Clinic
Full name of responsible person
Dr. Payam Varedi
Street address
No 35, Gandi avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciences
Full name of responsible person
Dr. Gholamreza Shirani
Street address
4th floor, Ghods Avenue, Keshavarz bolivar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran university of medical sciences, Faculty of Dentistry,
Full name of responsible person
Dr Payam Varedi
Position
Resident in Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Next to the Nuclear Energy Center, North Kargar avenue
City
Tehran
Postal code
Phone
+98 21 8801 5878
Fax
Email
payam.varedi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of dentistry
Full name of responsible person
Dr Gholamreza Shirani
Position
Assitant Professor
Other areas of specialty/work
Street address
Next to Nuclear Energy Cente, North Kargar avnenue
City
Tehran
Postal code
Phone
+98 21 8801 5878
Fax
Email
payam.varedi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences, Faculty of dentistry
Full name of responsible person
Payam Varedi
Position
Resident in Oral & Maxillofacial Surgery
Other areas of specialty/work
Street address
Next to the Nuclear Energy Center, North Kargar avenue
City
Tehran
Postal code
Phone
+98 21 84901
Fax
Email
payam.varedi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)