Comparing the results of pilonidal sinus surgery under video guide with minimally invasive hook circulators with routine method
Design
In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the two mentioned groups. For one group, the routine procedure will be performed and for the other group, Hook's circulators will be performed minimally invasively, and the results after surgery will be compared between the two groups.
Settings and conduct
This study is a randomized clinical trial (blocks of four), double blind (participants and results analyzer), with parallel groups, without a control group and with the participation of 80 patients with pilonidal sinus surgery referred to Imam Reza Hospital (Tabriz).
Participants/Inclusion and exclusion criteria
The inclusion criteria include: age over 18 years, consent to participate in the study and suffering from pilonidal sinus will be determined by the doctor, and the exclusion criteria will also include: history of uncontrolled blood pressure and recurrent pilonidal sinus.
Intervention groups
In this study, patients who will refer to the operating room due to pilonidal sinus surgery will undergo intervention. Patients will be randomly divided into two groups. For one group, the routine procedure will be performed and for the other group, Hook's circulators will be performed minimally invasively, and the results after surgery will be compared between the two groups.
Main outcome variables
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N43
Registration date:2024-02-10, 1402/11/21
Registration timing:prospective
Last update:2024-02-10, 1402/11/21
Update count:0
Registration date
2024-02-10, 1402/11/21
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-14, 1402/12/24
Expected recruitment end date
2025-03-14, 1403/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the results of pilonidal sinus surgery under video guide with minimally invasive hook circulators with routine method
Public title
Comparing the results of pilonidal sinus surgery under video guide with minimally invasive hook circulators with routine method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Consent to participate in the study
Having pilonidal sinus as diagnosed by a specialist doctor
Exclusion criteria:
History of uncontrolled blood pressure
Recurrent pilonidal sinus
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will divid into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of technique used, in this study they will not know what type of technique will be used in other patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-12-17, 1402/09/26
Ethics committee reference number
IR.TBZMED.REC.1402.708
Health conditions studied
1
Description of health condition studied
Infection
ICD-10 code
A04
ICD-10 code description
Other bacterial intestinal infections
Primary outcomes
1
Description
Infection
Timepoint
Once a week in the first thirty days after surgery
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The surgical procedure will be as follows: using hook circulators under the video guide, the pitting area of the pilonidal sinus is removed in a circular manner and entered into the sinus cavity, then electrical curettage is performed using hook circulators instead of mechanical curettage. Finally, the infection rate will be measured.
Category
Treatment - Devices
2
Description
Control group: The surgical procedure will be as follows, without using hook circulators, under the video guide, the pitting area of the pilonidal sinus is removed in a circular manner and entered into the sinus cavity, then electrical curettage is performed using hook circulators instead of mechanical curettage. Finally, the infection rate will be measured.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ramin Azhoogh
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available