Protocol summary

Study aim
investigate the effect of subperiosteal tunnel in lateral internal osteotomy on periorbital edema and ecchymosis and subconjunctival ecchymosis after rhinoplasty.
Design
For patients on one side of the nose, before the lateral osteotomy, the subperiosteal tunnel will be created by the periosteal elevator, and on the opposite side, the osteotomy will be performed without creating the subperiosteal tunnel and maintaining the periosteal adhesion. In each patient, which side will be osteotomy by which method is chosen randomly. Edema and ecchymosis on the 2nd and 7th days after surgery will be evaluated using the standard 5-grade Gokalan-kara periorbital edema and ecchymosis system by a third surgeon who does not know how to perform the surgery.
Settings and conduct
Imam Khomeini Hospital in Ahvaz All patients underwent open rhinoplasty, and one side of the nose of the subperiosteal tunnel was created by periosteal elevator, and on the opposite side, without creating a subperiosteal tunnel and maintaining periosteal adhesion, osteotomy was performed, and at the end, a splint was placed on the patient. After the surgery, a new dose of dexamethasone 8 mg is prescribed for all patients
Participants/Inclusion and exclusion criteria
Patients in need of rhinoplasty surgery. Patients with coagulation problems and a family history of bleeding disorders, patients with high blood pressure and patients with a history of taking anticoagulant drugs, Patients with a history of previous rhinoplasty, trauma will be excluded from the study.
Intervention groups
In each patient, a subperiosteal tunnel will be created by a periosteal elevator on one side of the nose randomly before the lateral osteotomy, and on the opposite side, the osteotomy will be performed without creating a subperiosteal tunnel and maintaining the adhesion of the periosteum.
Main outcome variables
edema and ecchymosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230624058563N1
Registration date: 2023-08-21, 1402/05/30
Registration timing: registered_while_recruiting

Last update: 2023-08-21, 1402/05/30
Update count: 0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Fatemeh AbediRad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
f.abedirad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of subperiosteal tunnel in internal lateral osteotomy on the amount of periorbital edema and ecchymosis and subconjunctival ecchymosis after rhinoplasty
Public title
The effect of subperiosteal tunnel in internal lateral osteotomy on the amount of periorbital edema and ecchymosis andsubconjunctival ecchymosis after rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cleft Lip and Palate Patients
Exclusion criteria:
Patients with coagulation problems and family history of bleeding disorders Patients with a history of taking anticoagulant drugs Patients with high blood pressure Previous history of rhinoplasty, trauma
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 23
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization For patients who have a subperiosteal tunnel created on the right side of the nose and the left side has no tunnel, an even number is considered, and for patients who have a subperiosteal tunnel created on the left side of the nose and the right side has no tunnel, an odd number is considered. will be Then we will extract the relevant numbers from the table of random numbers according to the number of the studied sample. Each number is written on a card and placed in an envelope. The envelopes are sealed and the patient's number is written on each envelope. If the number inside the patient envelope is even, the subperiosteal tunnel is created on the right side, and if the patient number is odd, the subperiosteal tunnel is created on the left side.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluators of the outcome after the completion of the surgery did not know about the type and location of the osteotomy
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.AJUMS.REC.1402.132

Health conditions studied

1

Description of health condition studied
Patients in need of rhinoplasty surgery
ICD-10 code
.
ICD-10 code description
.

Primary outcomes

1

Description
edema
Timepoint
Second and seventh days after surgery
Method of measurement
The objective scale based on Kara et al.'s study has 4 grades for edema

2

Description
ecchymosis
Timepoint
Second and seventh days after surgery
Method of measurement
The objective scale based on Kara et al.'s study has 4 grades for ecchymosis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a side of the nose, before the lateral osteotomy, the subperiosteal tunnel will be created by periosteal elevator
Category
Treatment - Surgery

2

Description
Control group: On the opposite side, osteotomy was performed without creating a subperiosteal tunnel and maintaining periosteal adhesion
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ahvaz
Full name of responsible person
Fatemeh AbediRad
Street address
Ahvaz, 24 meter street, twenty four meter street, Ahvazian street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2818
Email
f.abedirad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh AbediRad
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
f.abedirad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh AbediRad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
f.abedirad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh AbediRad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
f.abedirad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh AbediRad
Position
Ahvaz
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
f.abedirad@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
The unwillingness of the researcher to publish data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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