Laser and Phenol Treatment for Pilonidal Sinus

NCT ID: NCT07022899

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2026-06-25

Brief Summary

This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients.

Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. It happens when hair gets trapped under the skin, causing pain, swelling, and infection. This condition mainly affects young adults and can interfere with work and daily activities.

The study compares three minimally invasive treatments:

1. Laser therapy alone: A thin laser fiber is inserted into the sinus to destroy the lining and close the tunnel using local anesthesia as an outpatient procedure.

2. Phenol treatment alone: A chemical solution (phenol) is injected into the sinus to make it close and heal, done with local anesthesia in the clinic.

3. Combined laser and phenol therapy: Both treatments are used together for potentially better healing with lower recurrence rates.

Researchers will measure healing rates, healing time, recurrence rates, pain levels, complications, patient satisfaction, and return to normal activities.

This research is important because there is no single "best" treatment for pilonidal sinus. Traditional surgery often requires general anesthesia, hospital stays, large wounds taking months to heal, significant scarring, long work absence, and high recurrence rates up to 30%.

These newer treatments offer faster healing, less pain and scarring, quicker return to normal life, and lower recurrence chance. By comparing these approaches directly, this study will help doctors and patients make better treatment decisions based on scientific evidence.

This is a prospective observational cohort study following patients who receive one of these three treatments. The study will include adults with pilonidal sinus disease suitable for minimally invasive treatment.

Detailed Description

Detailed Description şu şekilde olmalı (sample size dahil):

STUDY DESIGN AND METHODOLOGY

This prospective observational cohort study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery. The study aims to compare the clinical outcomes of three different minimally invasive treatment approaches for pilonidal sinus disease.

TREATMENT GROUPS

Group 1 - Laser Therapy: Patients will receive diode laser treatment using a radial fiber inserted into the pilonidal sinus tract. The procedure is performed under local anesthesia with lidocaine injection.

Group 2 - Phenol Treatment: Patients will receive crystallized phenol application into the sinus cavity after debridement of hair and debris. The procedure is performed under local anesthesia.

Group 3 - Combined Treatment: Patients will receive both laser therapy followed by phenol application in the same session under local anesthesia.

SAMPLE SIZE

This is a pilot comparative study designed to evaluate the feasibility and preliminary efficacy of three treatment approaches. Sample size will be determined based on patient availability and recruitment capacity during the study period. All eligible patients meeting inclusion criteria will be enrolled consecutively.

FOLLOW-UP SCHEDULE

Patients will be evaluated at 1 week, 1 month, 3 months, 6 months, and 12 months post-treatment.

PRIMARY ENDPOINTS

• Complete healing rate (absence of discharge, pain, and complete epithelialization)
• Recurrence rate at 12 months

SECONDARY ENDPOINTS

• Time to complete healing
• Post-operative pain scores (VAS)
• Complication rates
• Patient satisfaction scores
• Return to normal activities
• Quality of life assessment

STATISTICAL ANALYSIS

Categorical variables will be analyzed using Chi-square test. Continuous variables will be analyzed using appropriate parametric or non-parametric tests. Kaplan-Meier survival analysis will be used for time-to-healing assessment.

Conditions

Pilonidal Sinus Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laser Therapy Group Group Type: Other

Patients receiving diode laser treatment alone for pilonidal sinus disease

No interventions assigned to this group

Phenol Treatment Group

Patients receiving crystallized phenol application alone for pilonidal sinus disease

No interventions assigned to this group

Combined Treatment Group

Patients receiving both laser therapy and phenol treatment in combination for pilonidal sinus disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older
• Diagnosed chronic pilonidal sinus disease confirmed by clinical examination
• Suitable for minimally invasive treatment approaches
• Ability to provide informed consent
• Willingness to comply with follow-up schedule
• No contraindications to local anesthesia

Exclusion Criteria

• Active acute pilonidal abscess requiring emergency drainage
• Previous pilonidal sinus surgery or treatment
• Pregnancy or breastfeeding
• Immunocompromised patients (diabetes mellitus, immunosuppressive therapy, chronic corticosteroid use)
• Malignancy in the sacrococcygeal region
• Bleeding disorders or anticoagulant therapy that cannot be discontinued
• Allergy to local anesthetics (lidocaine)
• Mental incapacity or psychiatric illness preventing informed consent
• Geographic inaccessibility for follow-up visits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Adnan Gundogdu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ivstrh_pilonidal

Identifier Type: -

Identifier Source: org_study_id