Evaluation of the results and complications of phenol injection in the treatment of patients with simple pilonidal sinus referred to Imam Khomeini Hospital in ۲۰۲۳
Treatment of pilonidal sinus disease with fewer complications and a shorter recovery period
Design
A semi-experimental trial with one intervention group, on 20 patients, phase 3
Settings and conduct
Patients with mild form of pilonidal sinus referred to Imam Khomeini Hospital in 2023 will be included in the study.
after local anesthesia, the skin will be prepared . First, curettage and then phenol crystal injection will be done, and after the sinus contents are removed, washing and dressing will be done.
All patients will be followed up by phone call or visiting the clinic in person. Cases of pain, need for analgesia, discharge, infection and other complications, and duration of rest and time to return to normal activity will be recorded.
Participants/Inclusion and exclusion criteria
Patients with a mild form of pilonidal sinus (no lateral extension, no previous history of surgical treatment, no abscess)
Intervention groups
Intervention group: Use of phenol crystal
Main outcome variables
Pain; Need to receive painkillers, discharge or infection, time to return to normal life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230602058367N1
Registration date:2023-09-15, 1402/06/24
Registration timing:prospective
Last update:2023-09-15, 1402/06/24
Update count:0
Registration date
2023-09-15, 1402/06/24
Registrant information
Name
Mohammad Javad SheykhAboli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2112
Email address
mjavadsh14@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-30, 1402/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results and complications of phenol injection in the treatment of patients with simple pilonidal sinus referred to Imam Khomeini Hospital in ۲۰۲۳
Public title
results and complications of phenol injection in the treatment of patients with simple pilonidal sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with a simple form of pilonidal sinus (only having a secretory pit in the mid- line)
No previous history of surgical treatment
Exclusion criteria:
The presence of lateral extention (secretion pit on the outside of the midline).
presence of abscess
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Dr. Gharib Street- At the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.357
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
pain,
Timepoint
Periods of 1, 2, 3, 6, 9 and 12 months
Method of measurement
Call or visit the clinic in person
2
Description
need to take painkillers
Timepoint
Periods of 1, 2, 3, 6, 9 and 12 months
Method of measurement
Call or visit the clinic in person
3
Description
discharge or infection
Timepoint
Periods of 1, 2, 3, 6, 9 and 12 months
Method of measurement
Call or visit the clinic in person
4
Description
Rest period and time to return to normal activity
Timepoint
Periods of 1, 2, 3, 6, 9 and 12 months
Method of measurement
Call or visit the clinic in person
Secondary outcomes
1
Description
need to take painkillers
Timepoint
Periods of 1, 2, 3, 6, 9 and 12 months
Method of measurement
Call or visit the clinic in person
Intervention groups
1
Description
Among the patients with pilonidal sinus disease referred in 2023, people with a simple form of pilonidal sinus (with only a hole in the midline), without previous history of surgical treatment, will be selected as the inclusion criteria for the study.If there is a lateral extension (secreting hole on the outside of the midline) and an abscess, the patient will be excluded from the study (exclusion criteria).Among the selected people, different treatment methods will be explained. The advantages and disadvantages of using phenol will be explained, and if they are satisfied, the candidate will be treated with phenol crystal and will be included in the study.The required phenol crystal is provided through the Faculty of Pharmacy.After entering the study, on the day of surgery and after admitting the patient to the operating room, the patient lies in the prone position on the bed of the operating room. After exposing the surgical site and disinfecting the site with betadine (prep) and dropping them (drape), xylocaine/lidocaine anesthetic is injected. After obtaining the desired anesthesia, the surrounding area is lubricated with silver sulfadiazine or zinc oxide ointment (to protect the skin), probing is performed through the existing holes. After obtaining the size of the sinus by measuring the tip of the probe, the inside of the sinus is physically deepened by a curette and the material inside the sinus is removed. Then the phenol crystal will enter the sinus (the crystal will melt after contact with the body due to heat). After the effect of phenol, secretions and debris inside the sinuses will be removed. After finishing the work and cleaning the position, sterile dressing will be done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Javad Sheikh Aboli
Street address
Dr. Gharib StreetAt - the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2112
Email
mjavadsh14@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Research and Technology Vice-Chancellor,Central Organization of the University 6th floor, corner of Quds St, Keshavarz Blvd
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?