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NCT Number: NCT07369921

Pediatric Pilonidal Sinus Surgical Treatment

The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

Location status: Recruiting

Location contact

ZELİHA AKIŞ YILDIZ, MD

CONTACT

[email protected]

+90 5305255542

About this study

Pilonidal sinus disease (PSD) is common in young adults and causes repeated infection and inflammation in the sacrococcygeal region. It is most common in men between the ages of 20 and 30, which is why most publications about PSD are part of adult series.

This study aims to determine which treatment option is more effective and beneficial for patients with sacrococcygeal pilonidal sinus. Furthermore, it aims to contribute to more positive treatment outcomes by identifying the causes of recurrence and morbidity in patients. Sacrococcygeal pilonidal sinus is quite common in adolescents. Treatment options vary from non-operative to endoscopic surgery. However, recurrence still occurs with every technique. Patients suffer from long treatment processes and morbidity. Although the exact causes of recurrence are not fully understood, it is thought that the patient's demographic characteristics and treatment option play a role. Most studies are retrospective and compare at most two treatment options. This is one of the reasons why it is not possible to reach a definitive conclusion about which treatment is more effective. Also, the number of studies conducted in the adolescent age group is limited. By conducting study prospectively and randomized, aim to prevent biased results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having sacrococcygeal pilonidal sinus disease
  • written informed (family) consent were eligible for inclusion in this trial

Exclusion criteria

  • Being over 18 years old or under 12 years old
  • recurrent sacrococcygeal pilonidal sinus disease

Treatment and study plan

Crystallized Phenol Applied

Procedure

four different surgical methods for the treatment of sacrococcygeal pilonidal sinus

Other names: Endoscopy Group, Limberg Flap Group, Modified Limberg Flap Group

Primary outcomes

  1. complications

    Time frame: 30 days

    Recurrence

  2. pain score

    Time frame: 24 hours

    VAS score under 4,VAS score above 4

Secondary outcomes

  1. sinus volume measurement

    Time frame: 24 hours

    USG guided

Study contacts

Contact information is provided by the study sponsor or research team.

ZELİHA AKIŞ YILDIZ, md

CONTACT

[email protected]

+90 5305255542

Sponsors and collaborators

Lead sponsor

Zeliha Alicikus

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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