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Recruiting NCT07369921

Pediatric Pilonidal Sinus Surgical Treatment

No phase Interventional Surgery Pilonidal Sinus Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Crystallized Phenol Applied.
Who it may be relevant to
Registry conditions: Surgery, Pilonidal Sinus, Pediatric. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Crystallized Phenol Applied
    four different surgical methods for the treatment of sacrococcygeal pilonidal sinus

Primary outcome measures

  • complications [Time frame: 30 days]
  • pain score [Time frame: 24 hours]
Secondary outcome measures (1)
  • sinus volume measurement [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Umraniye Education and Research Hospital — Istanbul

Identifiers

NCT: NCT07369921 · Z.AKIŞ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗