Evaluation of success rate of piezosurgery technique in nasal hump reduction and comparison with conventional method: A randomized double blind clinical trial
The aim of the present study is to evaluate piezosurgery technique ability, in dorsal hump reduction during rhinoplasty. This study is randomized, double blind, with control, single center, phase-2 of clinical trial. Blinding is done for patients and the researcher who measures the outcomes. The main inclusion criterion is presence of a dorsal hump in patient who is candidate for primary rhinoplasty. The main exclusion criteria are history of bleeding in patient or his or her family; consumption of drugs which intervene with coagulation system; consumption of oral contraceptive drugs. Target sample size is 20 patients. In intervention group, hump reduction is done with piezosurgery technique. In control group, hump reduction is conducted with conventional method (osteotome and rasp). The time of this intervention is after primary tip plasty. Primary outcomes are symmetry of nasal dorsum, the compatibility rate of the amount of acquired hump reduction after surgery with the predetermined amount (during presurgical phase), the rate of patient’s satisfaction about final appearance of nasal dorsum. Secondary outcomes consist of: bony irregularities of nasal dorsum, bony prominence of nasal dorsum, cutaneous complications in nasal dorsum.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610219926N3
Registration date:2017-01-06, 1395/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Mohammad Reza Jamalpour
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1826 0356
Email address
jamalpour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellors of research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-01-07, 1395/10/18
Expected recruitment end date
2017-04-22, 1396/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of success rate of piezosurgery technique in nasal hump reduction and comparison with conventional method: A randomized double blind clinical trial
Public title
Using of piezosurgery technique in rhinoplasty for nasal hump reduction
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are presence of dorsal hump in a patient, who is candidate for primary rhinoplasty; ASA (American Society of Anesthesiologists) class I patients. The exclusion criteria are history of bleeding in patient or his or her family; consumption of drugs which intervene with coagulation system; consumption of oral contraceptive drugs; secondary nasal deformity.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blinding technique: It is stipulated in consent form that after participating of patient in this study, he or she will be treated randomly with one of the surgical techniques (piezosurgery or conventional method). The researcher who would measure the outcomes is a maxillofacial surgeon (other than the surgeon who has done the operations) and he do not know anything about groups.
Randomized allocation of samples to intervention and control groups will be done with blocked randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Hamadan University of Medical Sciences
Street address
No.16, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
City
Hamadan
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.UMSHA.REC.1395.250
Health conditions studied
1
Description of health condition studied
Nasal deformity
ICD-10 code
XVII
ICD-10 code description
Q10-Q18 Congenital malformations of eye, ear, face and neck
Primary outcomes
1
Description
Symmetry of nasal dorsum
Timepoint
Ten days, 4 weeks, 3 monthes after intervention
Method of measurement
Questionnaire
2
Description
Compatibility rate of the amount of acquired hump reduction after surgery with the predetermined amount (during presurgical phase)
Timepoint
Three monthes after iontervention
Method of measurement
Questionnaire
3
Description
Rate of patient’s satisfaction about final appearance of nasal dorsum
Timepoint
Three monthes after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Bony irregularities of nasal dorsum
Timepoint
Ten days, 4 weeks, 3 monthes after intervention
Method of measurement
Questionnaire
2
Description
Bony prominence of nasal dorsum
Timepoint
Ten days, 4 weeks, 3 monthes after intervention
Method of measurement
Questionnaire
3
Description
Cutaneous complications in nasal dorsum
Timepoint
Ten days, 4 weeks, 3 monthes after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Hump reduction is done with piezosurgery technique.
Category
Treatment - Surgery
2
Description
Hump reduction is conducted with osteotome and rasp.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad Reza Jamalpour
Street address
No.20, Mazdaghineh street, Shahid Behshti street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Askarinia
Street address
No.14, Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellors of Research and Technology, 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
Mohammad Reza Jamalpour
Position
Associated Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No.18, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Position
Associated professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No.18, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Position
Associated professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No.18, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)