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Comparison of the outcome of two methods of pilonidal sinus surgery, tie-over and simple repair during 2023-2024 in patients admitted to Shahrekord Ayatollah Kashani Hospital.

Protocol summary

Study aim
Determining and comparing the results of two pilonidal sinus surgery methods, tie-over and simple repair, during 2023-2024 in patients admitted to Ayatollah Kashani Shahrekord Hospital.
Design
A single-blind clinical trial, with two intervention groups with a sample size of 220 people, in which each patient is randomly assigned to groups A and B. Group A undergoes pilonidal sinus surgery by tie-over method and group B undergoes pilonidal sinus surgery by simple repair method. This study was conducted from April 2023 to March 2024 and the patients will be followed up for 6 months. Randomization of patients is done by the researcher and based on the admission of patients in turn in each group A and B.
Settings and conduct
People who undergo pilonidal sinus surgery at Ayatollah Kashani Hospital in Shahrekord. After filing the hospitalization case, each patient goes to group A and B alternately, so that the first patient admitted after the start of the study is in group A and the next patient is in group B and continues in the same way until the last patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All male and female patients aged 15 to 50 who are diagnosed with sacral pilonidal sinus and complete the consent form. Exclusion criteria: patients with diabetes, weak immune system, cancer and collagen vascular disease.
Intervention groups
Patients who undergo pilonidal sinus surgery by tie-over method Patients who undergo pilonidal sinus surgery with a simple repair method
Main outcome variables
Comparing the results of pilonidal sinus surgery based on age, sex, occupation, marital status, post-operative pain, post-operative infection, recurrence rate, bleeding rate and patient satisfaction rate in two methods of pilonidal sinus surgery by tie-over method with a simple repair method.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240302061141N1
Registration date: 2024-05-28, 1403/03/08
Registration timing: retrospective

Last update: 2024-05-28, 1403/03/08
Update count: 0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Behrooz Behzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 7273
Email address
behbehzadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome of two methods of pilonidal sinus surgery, tie-over and simple repair during 2023-2024 in patients admitted to Shahrekord Ayatollah Kashani Hospital.
Public title
Comparison of the outcome of two methods of pilonidal sinus surgery, tie-over and simple repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male and female patients diagnosed with sacral pilonidal sinus The age of patients entering the study is 15 to 50 years Patients who have completed the consent form
Exclusion criteria:
Patients with diabetes Patients with weak immune system Patients with cancer Patients with collagen vascular disease
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are randomly and equally divided into two groups A (tie-over surgery) and B (simple repair surgery) (each patient goes to group A and B alternately After filing the hospital admission file, so that the first patient After the start of the study placed in group A and the next patient is placed in group B, and so on until the last patient. Due to the fact that the patients must be informed about the type of operation and due to the fact that the researcher will perform the surgery himself, blinding is not possible at this stage, but after collecting the samples and providing the information to the analyst, blinding will be done and analysis is done based on the first and second groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
No. 25, 26 Alley, Varzesh Ave.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854476
Approval date
2024-04-06, 1403/01/18
Ethics committee reference number
IR.SKUMS.MED.REC.1403.004

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
Age of people by year
Timepoint
Knowing the patient's age when admitted to the hospital
Method of measurement
Hospital admission file

2

Description
Gender of the patient
Timepoint
Knowing the patient's gender when admitted to the hospital
Method of measurement
Hospital admission file

3

Description
Patient's job
Timepoint
Information about the patient's occupation at the beginning of the study
Method of measurement
through a questionnaire

4

Description
Marital status of the patient
Timepoint
At the beginning of the study when the patient was admitted
Method of measurement
Hospital admission file

5

Description
The amount of pain after surgery
Timepoint
Day 1 and day 6 after surgery
Method of measurement
through a questionnaire

6

Description
Postoperative wound infection
Timepoint
6th day and 6 months after surgery
Method of measurement
Clinical examination of the patient

7

Description
Recurrence of the disease
Timepoint
6 months after the operation
Method of measurement
Clinical examination of the patient

8

Description
Bleeding from the operation site
Timepoint
1 and 6 days after surgery
Method of measurement
Clinical examination of the patient

9

Description
Postoperative satisfaction rate
Timepoint
6 days and 6 months after surgery
Method of measurement
through a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: In the simple repair method, the pilonidal sinus is completely removed. After the hole is completely washed, a No. 14 hemovac drain will be inserted into the incision and exit from the upper part of the incision, and a cover will be used to suck blood from the wound. Then 0-2 Vicryl will be used to press the subcutaneous tissue together and the skin will be repaired using 0-3 nylon.
Category
Treatment - Surgery

2

Description
The second intervention group: First, an elliptical incision will be made on their skin and the sinus will be completely removed up to the perisacral fascia. Then, using a cover, the subcutaneous tissue and skin will be removed from the medius and two flaps will be created on both sides of the wound. After completely washing the hole and removing the blood using the cover, and if there is no bleeding, the skin and subcutaneous tissue and the entire presacral fascia will be sutured using 3 tension stitches using nylon 0-1, the cut in the upper and middle part will be sutured. . After this step, the freed flaps will be sutured together using absorbable suture (0-2 Vicryl). Then the subcutaneous tissue is brought together. In the last step, the layers of the skin are brought together using 0-3 nylon with round and close sutures so that the edges of the wound are overlapped.Then a bandage will be placed on the wound and it will be closed using tension stitches.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Ayatollah Kashani Hospital
Full name of responsible person
Behrooz Behzadi
Street address
Ayatollah Kashani Hospital, Parastar Blvd.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
Behbehzadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Reisi
Street address
Ayatollah Kashani Hospital, parastar Blvd.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
behbehzadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Behrooz Behzadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 25, 26 Alley., Varzesh Ave., Shahrekord Town,
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854476
Phone
+98 35 3623 7273
Fax
Email
behbehzadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Behrooz Behzadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 25, 26 Alley., Varzesh Ave., Shahrekord Town,
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854476
Phone
+98 35 3623 7273
Fax
Email
behbehzadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Behrooz Behzadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 25, 26 Alley., Varzesh Ave., Shahrekord Town,
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854476
Phone
+98 35 3623 7273
Fax
Email
behbehzadi@yahoo.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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaire form and informed consent as well as clinical examination results that have been recorded
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
The data is accessible to researchers working in academic institutions
Under which criteria data/document could be used
The use of the delivered data is allowed only for a more detailed examination and to help choose the preferred method of pilonidal sinus surgery. Statistical analysis to help further research is allowed
From where data/document is obtainable
Dr Behrooz Behzadi Email : behbehzadi@yahoo.com mobile : 09137293913
What processes are involved for a request to access data/document
After contacting via e-mail or phone call or text message, after identifying the requester and ensuring that the data is not misused, the file containing the data will be sent to them.
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