Protocol summary

Study aim
Comparison of the results of Swing Flap surgery repair of pilonidal sinus with secondary repair
Design
Two arm parallel group non randomised trial with non-blinded postoperative care and outcome assessment
Settings and conduct
100 patients with pilonidal sinus referred to shohadaye ashayer hospital after examination and having the inclusion criteria and the absence of exclusion criteria are divided into two groups of 50, one group undergoing open surgery and one group undergoing Swing flap and then during six months follow-up based on a questionnaire and doctor's examination variables are examined
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients referring to Shohada-e-Ashayer and Rahimi Hospital in Khorramabad for pilonidal sinus surgery 2- Satisfaction to participate in the study Exclusion criteria: 1- People who have pilonidal sinus abscess 2- People with recurrence of the pilonidal sinus 3- Patients with purulent hydroadenitis in the sacrococcygeal area 4 - People who have risk factors for wound healing (such as iron deficiency anemia, malnutrition, immunodeficiency, diabetes and the use of corticosteroids and anti-metabolic drugs) 5- Pregnant women 6- Dissatisfaction to participate in the study
Intervention groups
Two groups of 50 patients are divided randomly. For one group, surgery with secondary repair method (The control group) and for the second group, surgery with swing flap (The intervention group) .
Main outcome variables
Body mass index, Type of surgery, Duration of surgery, Postoperative site infection, Amount and severity of hematoma and postoperative site bleeding, Site seroma, Flap necrosis, recurrence of the disease, Time interval between recurrence of the first surgery, Severity of postoperative site pain, Scarring Wound , Wound opening, Wound healing time, Return to daily work time and Patient satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210926052604N1
Registration date: 2021-10-21, 1400/07/29
Registration timing: registered_while_recruiting

Last update: 2021-10-21, 1400/07/29
Update count: 0
Registration date
2021-10-21, 1400/07/29
Registrant information
Name
Seyed ahmad Seyed alagheband
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5893
Email address
ahmadalagheband@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of pilonidal sinus repair with methods of swing flap and secondary intension
Public title
Comparison of the results of pilonidal sinus repair with methods of swing flap and secondary intension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study Patients referred to Shohada Ashayer Hospital in Khorramabad for pilonidal sinus surgery
Exclusion criteria:
Patient with pilonidal sinus abscess Patient with recurrence of the pilonidal sinus Patients with purulent hydroadenitis in the sacrococcygeal region Patient who have risk factors for wound healing (such as iron deficiency anemia, malnutrition, immunodeficiency, diabetes and the use of corticosteroids and anti-metabolic drugs) pregnant women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan university of medical sciences
Street address
Enghelab Blvd shohadaye ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.LUMS.REC.1399.259

Health conditions studied

1

Description of health condition studied
Pilonidal sinus
ICD-10 code
L05.92
ICD-10 code description
Pilonidal sinus without abscess

Primary outcomes

1

Description
Duration of operation
Timepoint
Operation time
Method of measurement
Time to minutes

2

Description
Postoperative site Infection
Timepoint
First week and Second weak after surgery
Method of measurement
Doctor examination

3

Description
Hematoma and postoperative bleeding
Timepoint
First week and second week after surgery
Method of measurement
Doctor examination

4

Description
Surgery site seroma
Timepoint
1week and 2week and 1month after surgery
Method of measurement
Doctor examination

5

Description
Flap necrosis
Timepoint
1weak and 2weak after surgery
Method of measurement
Doctor examination

6

Description
Recurrence of disease
Timepoint
3month and 6month after surgery
Method of measurement
Doctor examination

7

Description
Interval of recurrence of the disease from the first surgery
Timepoint
6 month after surgery
Method of measurement
Doctor examination

8

Description
Severity of postoperative position pain
Timepoint
1weak and 2weak and1month and 3month after surgery
Method of measurement
Visual analogue scale questionnaire

9

Description
Surgical site scar
Timepoint
1month and 6month after surgery
Method of measurement
Doctor examination

10

Description
Wound dehiscence
Timepoint
1weak and 2weak and 1month after surgery
Method of measurement
Doctor examination

11

Description
Time of wound healing
Timepoint
3month and 6month after surgery
Method of measurement
Doctor examinatiob

12

Description
Return time to daily work
Timepoint
1 month and 3month after surgery
Method of measurement
Questionnaire

13

Description
Postoperative satisfaction
Timepoint
6month after surgery
Method of measurement
Licrd satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pilonidal sinus repair by swing flap surgery. In this method, the wound repair by displacement of adjacent tissue after removig of pilonidal sinus.
Category
Treatment - Surgery

2

Description
Control group: pilonidal sinus repair by secondary method. the wound is left open and is not repaired In this method, after removing the pilonidal sinus.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye ashayer hospital
Full name of responsible person
Seyed-ahmad seyed-alagheband
Street address
Shohadaye ashayer hospital,Enghelab Blvd, khorramabad city
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Phone
+98 66 3330 5006
Email
Ahmadalagheband@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
3 km Khorramabad-Borujerd, University of Medical Sciences Complex, Vice Chancellor for Research and Technology
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Phone
+98 66 3312 0172
Email
e_falahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed-Ahmad Seyed-Alagheband
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Enghelab Blvd shohadaye ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Phone
+98 66 3330 5006
Email
Ahmadalagheband@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed-ahmad seyed-alagheband
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Enghelab Blvd Shohadaye ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Phone
+98 66 3330 5006
Email
Ahmadalagheband@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed-Ahmad Seyed-Alagheband
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shohadaye ashayer hospital,Enghelab Blvd,khrramabad
City
Khorramabad
Province
Lorestan
Postal code
1438863184
Phone
0098 66 3305006
Email
Ahmadalagheband@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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