Compassion of postoperative edema & echymosis in rhinoplasty patients who undergone lateral nasal osteotomy with two different kinds of instrument ( piezosurgery versus hammer & osteotomy): clinical trial
The aim of this study is to evaluate the ability of piezosurgery for lateral nasal osteotomy in rhinoplasty patients. Inclusion criteria are healthy volunteer patients & exclusion criteria are: people with severe nasal deformity resulted from trauma or congenital e.g lip and palate cleft; systemic diseases which interfere with coagulation & drug therapy. Patients selection are based on convenient sampling. Selection of patients will be performed from those people refer to maxillofacial clinic of Hamadan Besat Teaching Hospital. Sample size is about 20 patients that will be divided randomly into two equal groups. In the first group, lateral nasal osteotomy will be done by piezosurgery and the second group by hammer & osteotom. The operations will be performed under general endothracheal anesthesia. In the second & seventh postoperative days, the severity of periorbital oedema & echymosis will be rated based on Cara & Gokalan scoring system.The results will be compared in two groups by statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060922638N1
Registration date:2015-07-17, 1394/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Kamal Faraji
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 5863
Email address
k.faraji@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-07-16, 1394/04/25
Expected recruitment end date
2016-01-15, 1394/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compassion of postoperative edema & echymosis in rhinoplasty patients who undergone lateral nasal osteotomy with two different kinds of instrument ( piezosurgery versus hammer & osteotomy): clinical trial
Public title
Rhinoplasty
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: healthy human volunteer Exclusion criteria: sever nasal deformity; systemic diseases which interfere with coagulation & drug therapy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Hamedan University of Medical Sciences
Street address
Students Research Center, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
6517619651
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
UMSHA.REC.1394.86IR
Health conditions studied
1
Description of health condition studied
edema
ICD-10 code
R60.0
ICD-10 code description
Localized oedema
2
Description of health condition studied
ecchymosis
ICD-10 code
R58
ICD-10 code description
Haemorrhage, not elsewhere classified
Primary outcomes
1
Description
Upper and lower eyelid edema
Timepoint
The second and seventh days after Rhinoplasty surgery
Method of measurement
According to the Cara & Gokalan scoring system
2
Description
Upper and lower eyelid ecchymosis
Timepoint
The second and seventh days after Rhinoplasty surgery
Method of measurement
According to the Cara & Gokalan scoring system
Secondary outcomes
empty
Intervention groups
1
Description
In control group, after performing an 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 case group, after performing an incision beside the piriform aperture, the piezoelectric instrument beak will be pushed through the tissue and osteotomy will be carry out in a continuous manner.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat teaching Hospital
Full name of responsible person
Dr. MohammadReza Jamalpour
Street address
Motahari Blvd.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Jamalpour
Street address
Students Research Center, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Jamalpour
Position
Assitant Professor
Other areas of specialty/work
Street address
Oral & maxillofacial Ward, Faculty of dentistry, Hamadan University of Medical Science
City
Hamadan
Postal code
6515935194
Phone
+98 81 3822 5863
Fax
Email
Jamalpour_omfs@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Jamalpour
Position
Assitant Professor
Other areas of specialty/work
Street address
Oral & maxillofacial Ward, Faculty of dentistry, Hamadan University of Medical Science، Hamadan
City
Hamedan
Postal code
6515935194
Phone
+98 81 3822 5863
Fax
Email
Jamalpour_omfs@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Kamal Faraji
Position
Resident in Oral & Maxillofacial Surgery
Other areas of specialty/work
Street address
Second floor, building No9, Golestan Alley, 18 meters Zulfiqar, Emaar Boulevard, Hamadan
City
Hamedan
Postal code
6515935194
Phone
+98 81 3822 5863
Fax
Email
hanakord@ymail.com; kamalfaraji20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)