Laser and Phenol Treatment for Pilonidal Sinus

NCT07022899 | Active Not Recruiting

• 1 other identifier: Ivstrh_pilonidal
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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

Conditions

Pilonidal Sinus Treatment

Keywords

Pilonidal Cyst Pilonidal Abscess Sacrococcygeal Pilonidal Sinus

Outcome Measures

Primary Outcomes (2)

• Complete Healing Rate

  Complete Healing Rate

  6 months

• Recurrence Rate

  Percentage of patients experiencing recurrence of pilonidal sinus disease defined as reappearance of symptoms, discharge, or new sinus formation at the treatment site

  12 months

Secondary Outcomes (3)

• Time to Complete Healing

  Up to 12 months

• Post-operative Pain Score

  1 week, 1 month, 3 months

• Complication Rate

  12 months

Study Arms (3)

Laser Therapy Group Group Type: Other

Patients receiving diode laser treatment alone for pilonidal sinus disease

Phenol Treatment Group

Patients receiving crystallized phenol application alone for pilonidal sinus disease

Combined Treatment Group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic pilonidal sinus disease seeking treatment at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, 34785, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: January 25, 2025
• Primary Completion: June 2, 2025
• Study Completion (Estimated): June 25, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)