Comparison of the effect of preoperative epinephrine injection on bleeding after oxidation of palynodinal sinus with the control group in patients referring to Ayatollah Taleghani hospital of Kermanshah
Comparison of the effect of preoperative epinephrine injection on bleeding after oxidation of pilonidal sinus with the control group in patients referring to Ayatollah Taleghani hospital of Kermanshah
Design
This study is one-blinded clinical trial.The study population will be included all patients with papelonidinal sinus referred to Taleghani hospital of Kermanshah.100 eligible patients will be selected conveniently and randomly will be assigned into intervention and control groups.
Settings and conduct
This study which will be conducted in Taleghani hospital of Keranshah city is one-blinded one, that the participants will not know which group they will be assigned
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who undergo Pelonidal sinus surgery for the first time. Be at least 14 years of age.
Exclusion criteria:Patients with ischemic heart disease, diabetes, hypertension, renal failure, acute infection and abscess; small size of the sinus
Intervention groups
In the intervention group, 3 CC epinephrine with a concentration of 1 / 10,000,000 is injected subcutaneously before surgery.In the control group, 3 cc of normal saline is injected and after 15 minutes surgery will begin.
Main outcome variables
Amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N121
Registration date:2019-05-19, 1398/02/29
Registration timing:prospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of preoperative epinephrine injection on bleeding after oxidation of palynodinal sinus with the control group in patients referring to Ayatollah Taleghani hospital of Kermanshah
Public title
The effect of epinephrine injection on bleeding after oxidation of palynodinal sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo Pelonidal sinus surgery for the first time
Be at least 14 years of age
Exclusion criteria:
Patients with ischemic heart disease, diabetes, hypertension, renal failure, acute infection and abscess
small size of the sinus
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using a random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participant will kept blinded to the allocation of study groups to the intervention and control groups, the dosage of the drug and the manufacturer of the medicine.In this way, the participants will be unaware of how the participants will be coded and how much drug they will received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
ir.kums.rec.1398.108
Health conditions studied
1
Description of health condition studied
Pilonidal sinus
ICD-10 code
L05
ICD-10 code description
Pilonidal cyst and sinus
Primary outcomes
1
Description
Amount of bleeding
Timepoint
Immediately after surgery
Method of measurement
Based on the number of gauze bandages that are completely soaked
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, 3 CC epinephrine with a concentration of 1 / 10,000,000 is injected subcutaneously before surgery.
Category
Treatment - Drugs
2
Description
In the control group, 3 cc of normal saline is injected and after 15 minutes surgery will begin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mehran Norozi
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0139
Email
Www.mehrannowroozi813@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehtan Norozi
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshtiq Blvd Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0139
Email
Www.mehrannowroozi813@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Arash Koohi
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0139
Email
Arash_koohi_ar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehran Norozi
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0139
Email
Www.mehrannowroozi813@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 40-day period, the documents will be sent e-mail