Pilonidal Sinus Disease
Conditions
Keywords
Pilonidal Sinus Disease, SiLac, Phenol, Sacrococcygeal Pilonidal Sinus
Brief summary
Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques. The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost. Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.
Detailed description
Pilonidal sinus disease (PSD) is a chronic inflammatory condition commonly affecting young adults and is associated with significant morbidity, including pain, recurrent infections, and impaired quality of life. Minimally invasive treatment approaches have gained popularity in recent years in order to reduce postoperative pain, shorten recovery time, and lower recurrence rates compared to conventional excisional surgery. Silac (laser ablation of the sinus tract) and phenol application are two minimally invasive techniques currently used in the management of primary pilonidal sinus disease. Although both methods are widely practiced, high-quality comparative evidence regarding their relative effectiveness remains limited. This prospective randomized controlled trial aims to compare Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients aged 18-64 years with primary disease, a maximum of three pits, and no more than two prior abscess episodes will be included. Patients with recurrent or secondary disease and significant comorbidities will be excluded. Participants will be randomly allocated in a 1:1 ratio to receive either Silac or phenol treatment. The primary outcome measure is recurrence rate during follow-up. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), wound healing time, time to return to work, patient satisfaction, and cost analysis. Patient recruitment will be conducted over a 6-month period. Each participant will be followed for 6 months after treatment, resulting in a total study duration of 12 months. Statistical analysis will be performed to compare outcomes between groups, with significance set at p \< 0.05.
Interventions
PROCEDURESiLac (Laser Ablation)
Laser ablation of the pilonidal sinus tract performed according to the study protocol.
PROCEDUREPhenol Application
Chemical ablation with phenol performed according to the study protocol.
Sponsors
Izmir City Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 64 years * Diagnosis of primary pilonidal sinus disease * Maximum of three sinus openings (pits) * History of no more than two previous abscess episodes * Ability to provide written informed consent
Exclusion criteria
* Recurrent or previously operated pilonidal sinus disease * More than three sinus openings * More than two previous abscess episodes * Acute abscess requiring emergency drainage at presentation * Presence of significant uncontrolled comorbidities * Pregnancy * Inability to comply with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 6 month | Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain (VAS Score) | Postoperative day 1 and week 1 | Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
| Postoperative Analgesic Consumption | Within the first postoperative week | Use of analgesic medication after treatment, measured as the proportion of patients requiring analgesics and/or the total number of analgesic doses used during the early postoperative period. |
| Wound Healing Time | Up to 6 months | Time required for complete epithelialization of the treated area without discharge. |
| Wound-Related Complications | Within 6 months after treatment | Occurrence of wound-related complications, including infection, abscess formation, cellulitis, seroma/hematoma, prolonged discharge (\>30 days), or need for additional medical or surgical intervention. Early (≤30 days) and late (\>30 days to 6 months) complications will be recorded separately. |
| Time to Return to Work | Within 6 months after treatment | Number of days from treatment to return to normal daily activities or work. |
| Patient Satisfaction | At 6 months after treatment | Patient-reported satisfaction with treatment outcome assessed using a standardized satisfaction scale. |
| Treatment Cost | During the 6-month follow-up period | Direct medical costs associated with each treatment method. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMehmet A Ugur
Outcome results
None listed