1. Home
  2. Approved trials
  3. » فارسی

Comparing Scalpel versus Electrocautery Methods for post auricular surgical site incision of tympanoplasty for patients with chronic otitis media

Protocol summary

Study aim
Evaluating the results of two post-auricular incision methods by scalpel or electrocautery to perform tympanoplasty.
Design
This study will be performed as a prospective, double-blind and randomized clinical trial. A total of 100 patients will undergo tympanoplasty by scalpel or electrocautery incision according to the randomization table and will be placed in 2 groups.
Settings and conduct
This study will be performed at the ENT, Head and Neck Surgery department of Taleghani Hospital, Tehran, Iran. Retrauricular skin and subcutaneous incision approach will be performed by electrocautery (group A) or scalpel (group B). Information is recorded and collected before, during or after surgery for all patients. Criteria related to site incision include: site of incision (post-auricular sulcus or along the posterior root line to sulcus), time of incision, wound characteristics (wound length), blood loss rate, incision site infection, ecchymosis, seroma Hematoma, Wound Detachment, Objective Scar Measurement (VSS), and Subjective Scar Score and Visual Analysis Scale (VAS). Patients and data analysts will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with chronic otitis media (COM) indicated for tympanoplasty with retro auricular approach Exclusion criteria: history of complication in other ear surgery
Intervention groups
Tympanoplasty will be performed with a scalpel or electrocautery incision of Retro-auricular skin and subcutaneous incision approach
Main outcome variables
frequency of infection, ecchymosis, hematoma, seroma, wound detachment and bleeding of surgical site incision, postoperative pain using VAS, amount of scar left by surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210210050316N1
Registration date: 2021-02-24, 1399/12/06
Registration timing: registered_while_recruiting

Last update: 2021-02-24, 1399/12/06
Update count: 0
Registration date
2021-02-24, 1399/12/06
Registrant information
Name
Sara Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4417 3663
Email address
sara.sharifi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Scalpel versus Electrocautery Methods for post auricular surgical site incision of tympanoplasty for patients with chronic otitis media
Public title
Comparing of 2 primary surgical incision methods in patients' eardrum repair surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic otitis media candidate for tympanoplasty with retroauricular approach
Exclusion criteria:
Active infection of other ear Retroauricular skin infection History of radiotherapy of head and neck Complications of surgical site incision of other ear collagen vascular disease Immunocompromised patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to 2 groups for tympanoplasty surgery by scalpel or electrocautery cutting, based on table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
1.A complete explanation of the study will be performed for the patients; And patients will be given a full explanation of the advantages and disadvantages of each surgical incision method, and if they consent, one of the studied methods will be done randomly, of which they will not be aware. 2. By numbering each of the groups into groups 1 and 2 in the statistical file, and not informing the person analyzing the information about their content
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical sciences
Street address
no4, 23 alley, south Parvaneh, West Ferdows, District 5
City
Tehran
Province
Tehran
Postal code
1483655418
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.MSP.REC.1398.565

Health conditions studied

1

Description of health condition studied
chronic Otitis Media
ICD-10 code
H65.3
ICD-10 code description
Chronic mucoid otitis media

Primary outcomes

1

Description
Complications of surgical site incision
Timepoint
day1 ,7, 30 and month6 after surgery
Method of measurement
Observation and checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: electrocautery retroauricular incision,
Category
Treatment - Surgery

2

Description
Intervention group2: scalpel retroauricular incision
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital, Tehran
Full name of responsible person
Sara Sharifi
Street address
department of ENT and head and Neck surgery, Taleghani hospital, Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 4417 3663
Email
sarasharifi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Street address
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 4417 3663
Email
sarasharifi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Sharifi
Position
Specialist Assistant of Head and neck surgery and ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No4, 23th Alley, South Parvaneh Ave, West Ferdows Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
111111111
Phone
+98 21 4417 3663
Fax
Email
saravel1212@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Sharifi
Position
Specialist Assistant of Head and neck surgery and ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No4, 23th Alley, South Parvaneh Ave, West Ferdows Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1483655418
Phone
+98 21 4417 3663
Fax
Email
saravel1212@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Sharifi
Position
Specialist Assistant of Head and neck surgery and ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No4, 23th Alley, South Parvaneh Ave, West Ferdows Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1483655418
Phone
+98 21 4417 3663
Fax
Email
saravel1212@yahoo.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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document
.
Comments
Loading...