Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
ID07369921

Comparison of Four Different Surgical Methods for the Treatment of Sacrococcygeal Pilonidal Sinus in Adolescents: A Randomized Controlled Trial

Led by Zeliha Alicikus · Updated on 2026-04-14

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating four different surgical treatment options for sacrococcygeal pilonidal sinus disease in adolescents aged 12 to 18 years. This condition causes repeated infections and inflammation near the tailbone area, commonly affecting young adults and adolescents. The study aims to determine which surgical method is most effective and beneficial, and to better understand causes of recurrence and complications by conducting a prospective, randomized trial. The study compares four surgical methods: crystallized phenol application, endoscopic sinus treatment (EPSiT), Limberg flap surgery, and modified Limberg flap surgery. Each treatment involves cleaning and removing affected tissue using different techniques, with hospital stays varying from one to three days depending on the method. Treatments include antiseptic cleaning, curettage, phenol application, sinus irrigation, cauterization, and flap excision with drainage catheters. Participants will undergo evaluations including pain scoring within 24 hours and monitoring for complications within 30 days after treatment. Sinus volume measurements will also be taken at 24 hours. The study is randomized with single-blinding, and patient outcomes will be tracked closely to assess the benefits and risks of each surgical option. The total participation period involves immediate post-treatment assessments and short-term follow-up to monitor recovery and complications.

CONDITIONS

Brief Title

Pediatric Pilonidal Sinus Surgical Treatment

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Having sacrococcygeal pilonidal sinus disease
  • Providing written informed consent (participant or family) for trial participation
  • Age between 12 and 18 years old
Not Eligible

You will not qualify if you...

  • Age under 12 years or over 18 years
  • Having recurrent sacrococcygeal pilonidal sinus disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day for Crystallized Phenol group or 3 days for surgical flap groups

Participants undergo one of four different surgical methods to treat sacrococcygeal pilonidal sinus and receive immediate care after surgery.

1 hospitalization period depending on surgical method

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for complications and pain following surgery to assess recovery and treatment outcomes.

Approximately 2 to 3 follow-up visits during the first month

Trial Site Locations

Total: 1 location

1

Umraniye Education and Research Hospital

Istanbul, Umraniye, Turkey (Türkiye), 34734

Actively Recruiting

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Research Team

Z

ZELİHA AKIŞ YILDIZ, md

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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