Evaluation of the results of pilonidal sinus surgery by Kardidakis flap method in comparison with open surgery method
Design
All patients referred to the surgical ward of Imam Reza Hospital in Mashhad with a diagnosis of pilonidal sinus during 1401-1402 undergo closed surgery by one surgeon and another by open method after obtaining informed consent and explaining the type of operation to the patient. After the operation, the first day in the ward and the first week in the clinic and the first month are examined by phone for recurrence, infection, pain at the operation site, etc., and then they are analyzed by statistical tests.
Settings and conduct
All patients referred to the surgical ward of Imam Reza Hospital in Mashhad with a diagnosis of pilonidal sinus during 1401-1402 undergo closed surgery by one surgeon and another by open method after obtaining informed consent and explaining the type of operation to the patient. After the operation, the first day in the ward and the first week in the clinic and the first month are examined by phone for recurrence, infection, pain at the operation site, etc., and then they are analyzed by statistical tests.
Participants/Inclusion and exclusion criteria
Patients with a diagnosis of pilonidal sinus disease
Patient with recurrence of pilonidal sinus disease
Intervention groups
In the group of patients who undergo the intervention, the surgery is performed with a closed method with the cardidakis flap.
Main outcome variables
Wound closure time / Patient pain / Wound infection / Relapse / Time to return to work
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051862N1
Registration date:2022-04-29, 1401/02/09
Registration timing:registered_while_recruiting
Last update:2022-04-29, 1401/02/09
Update count:0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Morteza Tavasolizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 4388
Email address
drmorteza20@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of pilonidal sinus surgery with Kardidakis flap method in comparison with open method
Public title
Evaluation of the results of pilonidal sinus surgery with Kardidakis flap method in comparison with open method in Imam Reza Hospital in 2022-2023
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of pilonidal sinus disease
Patient with recurrence of pilonidal sinus disease
Exclusion criteria:
Patients with pilonidal sinus abscess
Patient non-cooperation
Dissatisfaction with closed pilonidal sinus surgery
Diseases such as diabetes, connective tissue disease, etc., which delay the healing time of the wound
Patients taking corticosteroids, which delays wound healing time
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Mashhad University of Medical Sciences
The day after surgery and then one week and one month after surgery
Method of measurement
McGill Pain Questionnaire Observation and examination of patients
2
Description
Wound Infection
Timepoint
The day after surgery and then one week and one month after surgery
Method of measurement
Clinical observation
3
Description
Time to return to work
Timepoint
The day after surgery and then one week and one month after surgery
Method of measurement
Phone call
4
Description
Wound closure time
Timepoint
One month after surgery
Method of measurement
Patient examination
5
Description
Recurrence of the disease
Timepoint
One year after surgery
Method of measurement
Phone call
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, which is a closed surgery, after sterilizing the field with betadine, the pilonidal sinus site is marked with a marker, then to reduce bleeding into it, a solution of epinephrine diluted with -100 cc Sterile serum is injected. The operation site is removed with a razor blade and removed. After controlling the bleeding, a drain is placed in the wound floor to drain the wound, then the subcutaneous tissue and skin are repaired in three layers.
Category
Treatment - Surgery
2
Description
Control group: In this group, open surgery is performed in such a way that after sterilizing the surgical site with betadine, the sinus location is determined with the help of a marker and injection of die into it. Then, from the control of bleeding and washing the place with sterile serum, the place is bandaged with wet gas and left open.