Comparison of septoplasty with and without nasal packing on the complications and outcomes of surgery in patients who are candidate for septoplasty: a randomized clinical trial
To compare septoplasty with and without nasal packing on the complications and outcomes of surgery in patients who are candidate for septoplasty
Design
This is a randomized clinical trial, in which 56 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are candidate for septoplasty and will refer to Besat Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Candidate for septoplasty
Exclusion criteria:
Incidence of trauma after surgery;
A history of nasal granulomatosis;
Need for turbinate surgery
Intervention groups
Intervention group: Septoplasty with nasal packing including a narrow and long dressing bandage smeared with tetracycline ointment
Control group: Septoplasty without nasal packing including
Main outcome variables
Primary outcome:
Measuring pain
Measuring anxiety
Assessing the quality of breathing and sleep
Secondary outcome:
Measuring the severity of bleeding and leakage
Measuring the septal hematoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N243
Registration date:2018-10-17, 1397/07/25
Registration timing:registered_while_recruiting
Last update:2018-10-17, 1397/07/25
Update count:0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of septoplasty with and without nasal packing on the complications and outcomes of surgery in patients who are candidate for septoplasty: a randomized clinical trial
Public title
Comparison of septoplasty with and without nasal packing on the complications and outcomes of surgery in patients who are candidate for septoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Candidate for septoplasty
Exclusion criteria:
Incidence of trauma after surgery;
A history of nasal granulomatosis;
Need for turbinate surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.UMSHA.REC.1397.91
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Measuring pain
Timepoint
24 hours, one week, and 3 months after surgery
Method of measurement
Using Visual Analog Scale (VAS)
2
Description
Measuring anxiety
Timepoint
24 hours, one week, and 3 months after surgery
Method of measurement
Usng standard questionnaire
3
Description
Assessing quality of breathing and sleep
Timepoint
24 hours, one week, and 3 months after surgery
Method of measurement
Through history taking
Secondary outcomes
1
Description
Measuring the severity of bleeding and leakage
Timepoint
24 hours and one week after surgery
Method of measurement
Through physical examination
2
Description
Measuring the septal hematoma
Timepoint
24 hours and one week after surgery
Method of measurement
Through physical examination
Intervention groups
1
Description
Intervention group: Septoplasty with nasal packing including a narrow and long dressing bandage smeared with tetracycline ointment
Category
Treatment - Surgery
2
Description
Control group: Septoplasty without nasal packing including
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Sahar Yousefnejad
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Sahar.yousefnejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sahar Yousefnejad
Position
Resident of ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Sahar.yousefnejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Elnaz Shariatpanahi
Position
ENT Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
e.shariatpanahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available