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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sacrococcygeal Pilonidal Sinus
• Intervention / Treatment: Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Françoise SCHMITT; Phone Number: +33 0241353637; Email: FrSchmitt@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric population

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.
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.; 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.
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.; 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.
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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate	Definition of failure: Absence of complete wound healing at 2 months, OR; Clinical recurrence of pilonidal sinus within 2 months	2 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Early (<30 days) and late complications; Graded according to Clavien-Madadi classification Through study completion, average 6 month	Up to 1 year
Time to complete wound healing	time in months	Up to 1 year
Length of hospital stay	duration of hospital stay in days	at hospital discharge
Postoperative pain duration		Up to 30 days
Postoperative pain Intensity		Up to 30 days
Analgesic consumption for postoperative pain	morphine equivalent dose	Up to 30 days
Predictive factors for recurrence	bivariate and multivariate analysis	Up to last follow-up
Recurrence rate	Through study completion, average 6 month	Up to 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Françoise SCHMITT, University hospital of Angers

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Recurrence; Wound healing; Surgical outcomes; Pilonidal sinus; Pediatric surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Cysts; Pathological Conditions, Signs and Symptoms; Recurrence; Pilonidal Sinus; Surgical Procedures, Operative
• Other Study ID Numbers: 49RC25_0350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No