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A comparative study of three open ,semi-closed, and closed surgical methods in the treatment of pilonidal sinus in terms of recovery time, side effects, and costs in the: A clinical trial double blined.

Protocol summary

Study aim
Determining the comparative study of three open, semi-closed, and closed surgical methods for the treatment of pilonidal sinus disease in terms of recovery time, complications, and costs.
Design
This study was designed as a double-blind randomized trial that was conducted on patients Under pilonidal sinus surgery, referring to Imam Khomeini (RA) hospital, Poldakhtar, it will be performed with 3 open, closed and semi-closed methods in 1402
Settings and conduct
Imam Khomeini Hospital, Poldakhtar
Participants/Inclusion and exclusion criteria
The entry criteria were 1- a candidate for pilonidal sinus surgery and 2- not having a history of pilonidal sinus surgery 3- not having diabetes and malignancy and the exit criteria were 1- the patient's unwillingness to cooperate, 2- the inability to communicate.
Intervention groups
In this study, in patients who are candidates for pilonidal sinus surgery, the intervention will be in the form of 3 methods: 1- leaving the wound open, 2- bringing the layers of the wound closer together, 3- closing the wound in the middle line.
Main outcome variables
Bleeding, pain, infection, recovery time, costs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230409057866N1
Registration date: 2023-04-27, 1402/02/07
Registration timing: registered_while_recruiting

Last update: 2023-04-27, 1402/02/07
Update count: 0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
somayh souri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 5108
Email address
sourisomayh88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-12, 1402/01/23
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of three open ,semi-closed, and closed surgical methods in the treatment of pilonidal sinus in terms of recovery time, side effects, and costs in the: A clinical trial double blined.
Public title
A comparative study of three open ,semi-closed, and closed surgical methods in the treatment of pilonidal sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for pilonidal sinus surgery No history of pilonidal sinus surgery Not having diabetes and malignancy
Exclusion criteria:
The patient's unwillingness to cooperate The patient's inability to communicate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers is used for randomization. direction Using the table of random numbers first to read the numbers of the determination table Numbers will then be considered for different groups to be On one of the numbers and in one of the directions in advance Determined to move and assign numbers to different groups we give.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blinded. Patients according to the type The intervention (each of the three methods of open, semi-closed, and closed surgery for the treatment of pilonidal sinus) is blinded, as well as the researcher who must enter the data into the checklist. The subject will be blinded to the type of intervention.
Placebo
Not used
Assignment
Other
Other design features
In this study, there are three groups and each will receive only one different intervention and only at one time

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-04-07, 1402/01/18
Ethics committee reference number
IR.UMSHA.REC.1402.024

Health conditions studied

1

Description of health condition studied
Pilonidal sinus
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Recovery time, pain, bleeding, infection, costs
Timepoint
during the intervention until one month after the intervention
Method of measurement
McGill questionnaire, Likert scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, in patients who are candidates for pilonidal sinus surgery, the intervention will be in the form of 3 methods: 1- leaving the wound open, 2- bringing the layers of the wound closer together, 3- and closing the wound in the middle line.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Poldakhtar
Full name of responsible person
Mohammad Hossein Ehsani
Street address
کوی بسیجیان ،بیمارستان امام خمینی پلدختر
City
Poldakhter
Province
Lorestan
Postal code
6851973117
Phone
+98 66 3222 8223
Email
sourisomayh88@gmail

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr.behzad imani
Street address
Tawheed Square, Shahid Fahmideh St
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
Webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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.behzad imani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
Behzadiman@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr.behzad imani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
behzadimani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr.behzad imani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street Research Square
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
behzadimani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Data received from participants will remain confidential but general results will be published without individual identification
When the data will become available and for how long
After completion of the research is accessible
To whom data/document is available
General
Under which criteria data/document could be used
It seeks to reduce the problems faced by patients with the aim of reducing complications and costs and quickly returning to work and society.
From where data/document is obtainable
Refer to the selected journal where the data is published to access the data
What processes are involved for a request to access data/document
Introduction to how to search and access valid sites and magazines
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