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Not yet recruitingNCT07470294PiloPediaUpdated Mar 13, 2026

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

An observational study in Sacrococcygeal Pilonidal Sinus, sponsored by University Hospital, Angers. Not yet recruiting. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
90
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sacrococcygeal Pilonidal Sinus

Keywords

  • Pilonidal sinus
  • Pediatric surgery
  • Recurrence
  • Wound healing
  • Surgical outcomes
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's planned enrollment of 90 is below the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Wide excision with open healing

    Intentional traditional treatment whitch consists in wide excision of the pilonidal sinus, and progressive healing of the wound thanks to daily dressing changes until complete closure is obtained.

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

  • Wide excision with primary midline closure

    Alternative technique using an immediate closure of the wound with layer of stiches, and regular dressings

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

  • Wide excision with primary midline closure and negative pressure wound therapy

    Alternative technique using an immediate closure of the wound with layer of stiches, completed with negative pressure therapy dressing, allowing for a fater recovery while requiring less dressing survey and changes.

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

  • Minimally invasive/endoscopic techniques

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

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

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.

06

What researchers measure

Primary outcomes

  1. Failure rate

    Definition of failure: * Absence of complete wound healing at 2 months, OR * Clinical recurrence of pilonidal sinus within 2 months

    Time frame: 2 months after surgery

Secondary outcomes

  1. Postoperative complications

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

    Time frame: Up to 1 year

  2. Time to complete wound healing

    time in months

    Time frame: Up to 1 year

  3. Length of hospital stay

    duration of hospital stay in days

    Time frame: at hospital discharge

  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

    morphine equivalent dose

    Time frame: Up to 30 days

  7. Predictive factors for recurrence

    bivariate and multivariate analysis

    Time frame: Up to last follow-up

  8. Recurrence rate

    Through study completion, average 6 month

    Time frame: Up to 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07470294
Responsible party
Sponsor
First posted
Mar 13, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Mar 13, 2026

Study contacts

Françoise SCHMITT
Contact
FrSchmitt@chu-angers.fr
0241353637 ext. +33
Françoise SCHMITT
principal investigator · University Hospital of Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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