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Not yet recruiting NCT07470294

Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population

Observational Sacrococcygeal Pilonidal Sinus

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: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques..
Who it may be relevant to
Registry conditions: Sacrococcygeal Pilonidal Sinus. Basic parameters: 0 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
Center list to be confirmed — check the primary protocol.
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

Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population: A 10-Year Single-Center Retrospective Comparative Cohort Study

Overview

Pilonidal sinus disease (PSD) in children is associated with significant morbidity and recurrence risk. Multiple surgical techniques are used, including excision with open healing, primary midline closure, off-midline closure, flap reconstruction, and minimally invasive approaches. However, high-quality comparative data in pediatric populations are limited, and adult data cannot be directly extrapolated. This single-center retrospective cohort study aims to compare the effectiveness of different surgical techniques used for curative treatment of PSD in children treated at CHU Angers between January 1, 2015 and March 31, 2025. The primary endpoint is surgical failure at 2 months, defined as absence of complete wound healing or early recurrence. Secondary outcomes include postoperative complications, time to healing, pain outcomes, length of hospital stay, and recurrence at 1 year. Results are expected to help optimize institutional management strategies and contribute to pediatric-specific evidence.

Detailed description

This is a single-center retrospective observational cohort study conducted in the Departments of Pediatric Surgery and Visceral Surgery at CHU Angers, France.

All consecutive patients under 18 years of age who underwent surgical treatment for pilonidal sinus disease between January 1, 2015 and March 31, 2025 will be included.

Surgical techniques analyzed include:

* Wide excision with open healing * Wide excision with primary midline closure * Wide excision with primary midline closure and negative pressure wound therapy * Minimally invasive/endoscopic techniques The primary objective is to compare treatment effectiveness at 2 months postoperatively. Secondary objectives include comparison of complication rates, healing delay, postoperative pain, and recurrence at 1 year, as well as identification of predictive factors for recurrence.

Data will be extracted from medical records and anonymized prior to statistical analysis.

Interventions

  • Procedure Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.
    curative treatment of pilonidal sinus, consisting in a wide excision followed by open healing or direct closure of the wound +/- negative pressure therapy dressing. Alterantivelly, an endoscopic procedure to destroy the pilonidal sinus can be performed.

Primary outcome measures

  • Failure rate [Time frame: 2 months after surgery]
Secondary outcome measures (8)
  • Postoperative complications [Time frame: Up to 1 year]
  • Time to complete wound healing [Time frame: Up to 1 year]
  • Length of hospital stay [Time frame: at hospital discharge]
  • Postoperative pain duration [Time frame: Up to 30 days]
  • Postoperative pain Intensity [Time frame: Up to 30 days]
  • Analgesic consumption for postoperative pain [Time frame: Up to 30 days]
  • Predictive factors for recurrence [Time frame: Up to last follow-up]
  • Recurrence rate [Time frame: Up to 1 year]

Eligibility criteria

Inclusion criteria

  • Age < 18 years at time of surgery
  • Surgical treatment for pilonidal sinus disease
  • Surgery performed between January 1, 2015 and March 31, 2025
  • Managed at CHU Angers (Pediatric or Visceral Surgery departments)
  • ICD-10 diagnosis code L05.9
  • CCAM procedure code QBFA007

Exclusion criteria

  • Emergency incision and drainage of acute pilonidal abscess (CCAM QBPA001)
  • Initial surgical management performed at another institution
  • Refusal of participation (patient and/or legal guardians, if applicable)
  • Alternative diagnosis (anal abscess, gluteal abscess)

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07470294 · 49RC25_0350

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗