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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07470294
Acronym
PiloPedia
Enrollment
90
Registered
2026-03-13
Start date
2026-04-01
Completion date
2026-08-31
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacrococcygeal Pilonidal Sinus

Keywords

Pilonidal sinus, Pediatric surgery, Recurrence, Wound healing, Surgical outcomes

Brief summary

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

PROCEDURESurgical 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Failure rate2 months after surgeryDefinition of failure: * Absence of complete wound healing at 2 months, OR * Clinical recurrence of pilonidal sinus within 2 months

Secondary

MeasureTime frameDescription
Analgesic consumption for postoperative painUp to 30 daysmorphine equivalent dose
Predictive factors for recurrenceUp to last follow-upbivariate and multivariate analysis
Recurrence rateUp to 1 yearThrough study completion, average 6 month
Time to complete wound healingUp to 1 yeartime in months
Length of hospital stayat hospital dischargeduration of hospital stay in days
Postoperative pain durationUp to 30 days
Postoperative pain IntensityUp to 30 days
Postoperative complicationsUp to 1 year* Early (\<30 days) and late complications * Graded according to Clavien-Madadi classification Through study completion, average 6 month

Contacts

CONTACTFrançoise SCHMITT
FrSchmitt@chu-angers.fr0241353637
PRINCIPAL_INVESTIGATORFrançoise SCHMITT

University Hospital of Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026