Objectives: To assess the effect of simple closure versus Limberg flap on initial repair in patients with sacrococcygeal pilonidal sinus.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with sacrococcygeal pilonidal sinus who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; sacrococcygeal pilonidal sinus.
Exclusion criteria: Infection of abscess in the area of pilonidal sinus; previous history of pilonidal sinus surgery.
Intervention group 1: Excision of cyst of pilonidal sinus and then repairing surgical area by simple and routine method.
Intervention group 2: Excision of cyst of pilonidal sinus and then repairing surgical area by Limberg flap method.
Primary outcome: Wound repair one week and then 1, 3 and 23 months after surgery through physical examination.
Secondary outcome: Assessing pain 3 and 6 hours after surgery by Visual Analog Scale (VAS).
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710109014N195
Registration date:2017-10-19, 1396/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of simple closure versus Limberg flap on initial repair in patients with sacrococcygeal pilonidal sinus: a randomized clinical trial
Public title
Effect of simple closure versus Limberg flap on initial repair in patients with sacrococcygeal pilonidal sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; sacrococcygeal pilonidal sinus.
Exclusion criteria: Infection of abscess in the area of pilonidal sinus; previous history of pilonidal sinus surgery.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.251
Health conditions studied
1
Description of health condition studied
Sacrococcygeal pilonidal sinus
ICD-10 code
L05
ICD-10 code description
Pilonidal cyst
Primary outcomes
1
Description
Wound repair
Timepoint
One week and then 1, 3 and 23 months after surgery
Method of measurement
Through physical examination
Secondary outcomes
1
Description
Assessing pain
Timepoint
3 and 6 hours after surgery
Method of measurement
By visual Analog Scale (VAS)
Intervention groups
1
Description
Intervention group 1: Excision of cyst of pilonidal sinus and then repairing surgical area by simple and routine method.
Category
Treatment - Surgery
2
Description
Intervention group 2: Excision of cyst of pilonidal sinus and then repairing surgical area by Limberg flap method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Abdollah Boostan Afrooz
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Abdollah Boostan Afrooz
Position
Resident of Surgery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr_boostan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Abdollah Boostan Afrooz
Position
Resident of Surgery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr_boostan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)