Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:33 AM
Study NCT ID:
NCT07470294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population
Sponsor:
University Hospital, Angers
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PiloPedia
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: