Objectives: Periorbital edema and ecchymosis are common complications of Lateral Osteotomy in rhinoplasty. The aim of this study is to compare periosteal Cutting’s and Elevating’s effects on the amount of bleeding, edema and ecchymosis in Lateral Osteotomy during rhinoplasty.
Design: The study is a not blinded random clinical trial with parallel assignment.
Setting and conduct: The study will be conducted at Imam Reza Hospital) affiliated to Tabriz University
of Medical Sciences( in Tabriz, Iran.
Participants including major eligibility criteria: This study will be conducted on 80 volunteer eligible cases for rhinoplasty. All enrolled cases are white and from the same ethnic group. The exclusion criteria are known bleeding or coagulation disorder.
Intervention: Operations will be under General Anesthesia (GA), using Total Intra Venous Anesthesia (TIVA) method. In one side of the nose, the approach will periosteal elevating before lateral osteotomy and the opposite side undergoes periosteal cutting without elevating. Side selection will be completely random. Injections to both sides will be performed in the same location and with the same dose. Also, similar osteotome with the same size will be applied for all patients by the same surgeon.
Main outcome measures (variables): Intraoperative bleeding volumes will be measured in separate suction bottles for each side. Postoperative edema and ecchymosis will be assessed by the ward residents unaware of operation variations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081123594N1
Registration date:2015-11-02, 1394/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Mehrnoush Mousavi-Aghdas
Name of organization / entity
Department of Otolaryngology, Children Hospital, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41333355921
Email address
mousavim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2006-12-21, 1385/09/30
Expected recruitment end date
2007-02-19, 1385/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing periosteal Cutting and Elevating in the amount of bleeding, edema and ecchymosis in Lateral Osteotomy during Rhinoplasty
Public title
Comparison of two Methods of Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
This study will be conducted on 80 volunteer eligible cases for rhinoplasty. All enrolled cases are white and from the same ethnic group. The exclusion criteriais known bleeding or coagulation disorder
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research Office, third floor, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Postal code
5165665931
Approval date
2006-12-22, 1385/10/01
Ethics committee reference number
85/3-5/7
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Y40, Y41,
ICD-10 code description
Complications of medical and surgical care
Primary outcomes
1
Description
Amount of intra-operational bleeding
Timepoint
During surgery
Method of measurement
Intraoperative bleeding volumes will be measured in separate suction bottles for each side.
2
Description
Edema
Timepoint
After surgery
Method of measurement
Postoperative edema will be assessed by the ward residents unaware of operation variations.
3
Description
Ecchymosis
Timepoint
After surgery
Method of measurement
Ecchymosis will be assessed by the ward residents unaware of operation variations.
Secondary outcomes
1
Description
No
Timepoint
No
Method of measurement
No
Intervention groups
1
Description
Operations will be under General Anesthesia (GA), using Total Intra Venous Anesthesia (TIVA) method. In one side of the nose, the approach will periosteal elevating before lateral osteotomy
Category
Treatment - Surgery
2
Description
Operations will be under General Anesthesia (GA), using Total Intra Venous Anesthesia (TIVA) method.The opposite side undergoes periosteal cutting without elevating. Side selection will be completely random .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mehrnoosh Mousaviagdas
Street address
Imam Reza Hospital, in front of Tabriz university of medical science, University Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Vice chancellor for research Office, third floor, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
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, 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
Full name of responsible person
Mehrnoosh Mousaviagdas
Position
Assistant professor of otorhinolaryngology
Other areas of specialty/work
Street address
Imam Reza Hospital, in front of Tabriz university of medical science, University Street
City
Tabriz
Postal code
Phone
+98 4133334705459
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrnoush Mousavi Aghdas
Position
Assistant professor of otorhinolaryngology
Other areas of specialty/work
Street address
Imam Reza Hospital, in front of Tabriz university of medical science, University Street
City
Tabriz
Postal code
Phone
+98 41352622506
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrnoush Mousavi Aghdas
Position
Assistant professor of otorhinolaryngology
Other areas of specialty/work
Street address
Imam Reza Hospital, in front of Tabriz university of medical science, University Street
City
Tabriz
Postal code
Phone
+98 4133334705459
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)