Laser Therapy, Pilonidal Sinus Disease
Conditions
Keywords
Minimally Invasive Treatment, Day Surgery
Brief summary
This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work. Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures. The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period. This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.
Detailed description
This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital. Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each): Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment Treatment Procedures: Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels. Group B receives local anesthesia, sinus area cleaning and curettage, crystallized phenol application into sinus channels, neutralization with saline after a specified time, followed by laser treatment. Both groups receive standard post-operative wound care instructions and same-day discharge. Follow-up Schedule: Preoperative assessment Postoperative visits at 2 weeks, 4 weeks, and 3 months Clinical examination for epithelialization status Pain assessment using Visual Analog Scale (VAS 0-10) Quality of life evaluation using SF-36 questionnaire Statistical Analysis: R software will be used for statistical analysis. Student's t-test or Mann-Whitney U test for continuous variables, chi-square test for categorical variables, and paired t-test for pre/post-treatment comparisons. Statistical significance set at p\<0.05. Primary Outcome: Time to complete epithelialization Secondary Outcomes: Postoperative pain scores, return to daily activities time, patient satisfaction, quality of life scores, and complication rates.
Interventions
PROCEDURELaser Treatment
Minimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity.
rystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation.
Sponsors
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study due to the nature of surgical interventions which cannot be blinded to participants or care providers
Intervention model description
Two parallel groups: Group A receives laser treatment only, Group B receives combined phenol and laser treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Primary pilonidal sinus disease * Three or fewer pit counts * Willing to participate in the study and signed informed consent form * Able to attend follow-up visits
Exclusion criteria
* Age under 18 years * More than three pit counts * Acute abscess presentation * Bilateral lateral extension * Recurrent pilonidal sinus disease * Immunocompromised patients * Patients unable to attend follow-up visits * Pregnancy (if applicable) * Severe comorbidities that contraindicate surgery under local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Epithelialization | From date of surgery until complete epithelialization is achieved, assessed up to 3 months | Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | Measured at 2 weeks, 4 weeks, and 3 months post-surgery | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable) |
| Return to Daily Activities Time | From date of surgery until return to normal activities, assessed up to 3 months | Time required for patients to return to normal daily activities and work, measured in days from surgery |
| Complication Rate | From surgery through 3 months follow-up | Incidence of post-operative complications including infection, wound dehiscence, bleeding, or other adverse events |
| Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction | At 3 months post-surgery | Patient satisfaction measured using Visual Analog Scale (VAS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate better satisfaction |
Countries
Turkey (Türkiye)
Outcome results
None listed