Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04681443 |
| Other study ID # |
Gulhane2020-146 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Gulhane Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pilonidal sinus disease is an acquired disorder of the natal cleft and its incidence is
reported as 6 in 100,000. Although there are many opinions regarding the treatment of
pilonidal sinus disease in the literature, surgery is the main treatment method. Regardless
of the treatment protocol, this disease has a certain risk of recurrence. Therefore, the
ideal treatment procedure for the pilonidal disease should be simple to perform, should allow
patients to return earlier to work, should be associated with minimal pain, and should
minimize financial cost.
Phenol application into the pilonidal sinus is an additional nonoperative adjunct to
treatment. This method is typically used after all hair and debris have been removed or
curetted from the sinus, and it helps to eliminate granulation tissue and further debris
formation. The injection is followed by hair control and strict hygiene. The use of phenol
causes an intense inflammatory reaction which destroys the epithelial lining, and care should
be taken to protect the surrounding skin. Pain is intense and may require inpatient admission
for pain control but success rates have been reported to range from 60% to 95%. However, it
is difficult to know which patients can expect enough benefit from phenol application.
The aim of the study is to evaluate the factors affecting the outcomes of patients with the
pilonidal disease treated with crystallized phenol and to evaluate long-term recurrence rates
of pilonidal disease treated with crystallized phenol.
Description:
Pilonidal sinus disease is an acquired disorder of the natal cleft and its incidence is
reported as 6 in 100,000. Although there are many opinions regarding the treatment of
pilonidal sinus disease in the literature, surgery is the main treatment method. Regardless
of the treatment protocol, this disease has a certain risk of recurrence. Therefore, the
ideal treatment procedure for the pilonidal disease should be simple to perform, should allow
patients to return earlier to work, should be associated with minimal pain, and should
minimize financial cost.
Phenol application into the pilonidal sinus is an additional nonoperative adjunct to
treatment. This method is typically used after all hair and debris have been removed or
curetted from the sinus, and it helps to eliminate granulation tissue and further debris
formation. The injection is followed by hair control and strict hygiene. The use of phenol
causes an intense inflammatory reaction which destroys the epithelial lining, and care should
be taken to protect the surrounding skin. Pain is intense and may require inpatient admission
for pain control but success rates have been reported to range from 60% to 95%. However, it
is difficult to know which patients can expect enough benefit from phenol application.
In this study, the procedure will be performed on an outpatient basis and the treatment
procedure will be performed in the prone position. Previously shaved sacrococcygeal area will
be cleaned with an antiseptic solution and local anesthesia will be achieved using 2%
lidocaine (1:100,000 adrenaline). After sinuses are dilated with a mosquito clamp; hair,
debris, and granulation tissue will be removed from the sinus tracts using a curved surgical
forceps and the tracts will be curetted using a straight curette. Following the protection of
the skin surrounding the sinus openings with a pomade and the perianal area with a sponge,
the sinus cavity will be sclerosed using crystallized phenol. Crystallized phenol will be
inserted into the sinus tract from the dilated sinus opening with a clamp until the tract is
full. This procedure will repeat twice and each phenol particles will remain in sinus about
one minute, and then will be removed by applying pressure. Consequently, the procedure will
be completed after dressing and the patient will be sent home by prescribing an analgesic
pill (paracetamol 500 mg) to use only when required.
After the patients are divided into two groups: (1) those successfully treated and (2) those
with treatment failure, descriptive statistics will be presented as the means +/- standard
deviations (SDs), medians and interquartile ranges (IQRs), and frequencies (%). Examinations
of normal distribution assumptions for continuous variables will be visually assessed with
quartile-quartile plots and histograms and confirmed with the Shapiro-Wilk test. Associations
between variables will be evaluated using the Mann-Whitney U and Student's t tests (for
continuous variables) or Pearson's chi-square and Fisher exact tests (for categorical
variables), where appropriate.
The association of treatment success with demographics, symptom duration, and pilonidal sinus
features such as the number and location of the sinuses, the amount of hair inside the sinus,
the volume of the sinus tract, and the length of sinus tract will be analyzed with logistic
regression analysis. First, each covariate will be analyzed in a univariate model, and all
variables with p-value less than 0.20 will be included in the final multivariate logistic
regression model to determine independent factors. Odds ratios (ORs) of statistically
significant predictors will be presented with 95% confidence intervals (CIs). P values lower
than 0.05 will be considered statistically significant.
