The aim of current study is to compare the treatment of pilonidal sinus with primary, secondary (open) and Limberg flap on treatment outcome and complications rate.
Design
In this clinical trial, 150 patients with pilonidal sinus will be randomly assigned to three 50 patients groups of treatment with primary methodm Limberg flap and secondary method.
Settings and conduct
Patients with pilonidal sinusvisiting Sina Hospital, Tabriz were treated after randomly allocation to three groups. Patients and the person evaluating the outcome were blinded to the allocation group.
First group will be treated with primary method, second group with Limberg flap and third group with secondary method.
Main outcome variables
Patients will be evaluated for recurrence and complications and improvement rate after one week, one months and three months post surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180606039985N1
Registration date:2018-09-17, 1397/06/26
Registration timing:retrospective
Last update:2018-09-17, 1397/06/26
Update count:0
Registration date
2018-09-17, 1397/06/26
Registrant information
Name
Hemmat Maghsoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7852
Email address
maghsudih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-04-03, 1396/01/14
Actual recruitment end date
2018-03-14, 1396/12/23
Trial completion date
2018-08-16, 1397/05/25
Scientific title
Comparison of primary closure, secondary closure (open) and Limberg flap for the treatment of pilonidal Sinus
Public title
Comparison of different closure methods for the treatment of pilonidal Sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary pilonidal sinus
Exclusion criteria:
Patients with relapse of pilonidal sinus
patients with pilonidal abcess
patients with diabetes mellitus
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the outcome will be blinded to the allocated group.
Placebo
Not 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
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.TBZMED.REC.1397.010
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
Pilonidal sinus recurrence
Timepoint
One week, one month and 3 months after surgery
Method of measurement
With physical examination
2
Description
Wound infection
Timepoint
One week, one month and 3 months after surgery
Method of measurement
With Physical examination
Secondary outcomes
1
Description
Complications
Timepoint
One week, one month and 3 months after surgery
Method of measurement
With physical examination
Intervention groups
1
Description
First group will undergo treatment of pilonidal sinus with primary method by two crescentic incisions and the cyst will be removed and then sutured .
Category
Treatment - Surgery
2
Description
Second group will undergo treatment of pilonidal sinus with Limberg flap metho with rhomboid incision, cyst removal, suture and hemovac insretion.
Category
Treatment - Surgery
3
Description
Third group will undergo treatment of pilonidal sinus with secondary method.by two crescentic incisions and the cyst will be removed but the cut is not closed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hemmat Maghsudi
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3333 5333
Email
maghsudih@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice-Chancellor of research, Tabriz University of Medical Sciences
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3333 5333
Email
skshakouri@gmail.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
Hemmat Maghsoudi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Fax
Email
dr.maghsoudi.89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hemmat Maghsoudi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Fax
Email
dr.maghsoudi.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hemmat Maghsoudi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Fax
Email
dr.maghsoudi.89@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document