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NCT Number: NCT07470294

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

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.

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Key information

Conditions

Sacrococcygeal Pilonidal Sinus Cysts Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pilonidal Sinus Recurrence

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.

Procedure

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 outcomes

  1. Failure rate

    Time frame: 2 months after surgery

    Definition of failure:

    • Absence of complete wound healing at 2 months, OR
    • Clinical recurrence of pilonidal sinus within 2 months

Secondary outcomes

  1. Postoperative complications

    Time frame: Up to 1 year

    • Early (<30 days) and late complications
    • Graded according to Clavien-Madadi classification Through study completion, average 6 month

  2. Time to complete wound healing

    Time frame: Up to 1 year

    time in months

  3. Length of hospital stay

    Time frame: at hospital discharge

    duration of hospital stay in days

  4. Postoperative pain duration

    Time frame: Up to 30 days

  5. Postoperative pain Intensity

    Time frame: Up to 30 days

  6. Analgesic consumption for postoperative pain

    Time frame: Up to 30 days

    morphine equivalent dose

  7. Predictive factors for recurrence

    Time frame: Up to last follow-up

    bivariate and multivariate analysis

  8. Recurrence rate

    Time frame: Up to 1 year

    Through study completion, average 6 month

Study contacts

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

Françoise SCHMITT

CONTACT

[email protected]

0241353637 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: PiloPedia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 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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