Sacrococcygeal Pilonidal SinusPiloPediaNCT07470294
Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population
An observational study of Sacrococcygeal Pilonidal Sinus, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Sacrococcygeal Pilonidal Sinus
- What is being tested?
- Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Sacrococcygeal Pilonidal Sinus
- Being tested
- Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.
- Keywords
- Pilonidal sinus, Pediatric surgery, Recurrence, Wound healing, Surgical outcomes
- Medical subject headings
- Pilonidal Sinus, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
Definition of failure:
- Absence of complete wound healing at 2 months, OR
- Clinical recurrence of pilonidal sinus within 2 months
Measured: 2 months after surgery
Secondary outcomes (8)
Postoperative complications
- Early (<30 days) and late complications
- Graded according to Clavien-Madadi classification Through study completion, average 6 month
Measured: Up to 1 year
Time to complete wound healing
time in months
Measured: Up to 1 year
Length of hospital stay
duration of hospital stay in days
Measured: at hospital discharge
Postoperative pain duration
Measured: Up to 30 days
Postoperative pain Intensity
Measured: Up to 30 days
Analgesic consumption for postoperative pain
morphine equivalent dose
Measured: Up to 30 days
Predictive factors for recurrence
bivariate and multivariate analysis
Measured: Up to last follow-up
Recurrence rate
Through study completion, average 6 month
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacrococcygeal Pilonidal SinusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Françoise SCHMITT, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470294
- Sponsor's protocol ID
- 49RC25_0350
- Acronym
- PiloPedia
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07470294
- Acronym / sponsor ID
- PiloPedia / 49RC25_0350
- Conditions
- Sacrococcygeal Pilonidal Sinus
- Keywords
- Pilonidal sinus, Pediatric surgery, Recurrence, Wound healing, Surgical outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wide excision with open healing | – | Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.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. |
| Wide excision with primary midline closure | – | Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.Alternative technique using an immediate closure of the wound with layer of stiches, and regular dressings |
| Wide excision with primary midline closure and negative pressure wound therapy | – | Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.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. |
| Minimally invasive/endoscopic techniques | – | Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Minimally invasive/endoscopic techniques, Wide excision with open healing, Wide excision with primary midline closure, Wide excision with primary midline closure and negative pressure wound therapy |
Primary outcome
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
8 secondary outcomes
Postoperative complications
Time frame: Up to 1 year
Time to complete wound healing
Time frame: Up to 1 year
Length of hospital stay
Time frame: at hospital discharge
Postoperative pain duration
Time frame: Up to 30 days
Postoperative pain Intensity
Time frame: Up to 30 days
Analgesic consumption for postoperative pain
Time frame: Up to 30 days
Predictive factors for recurrence
Time frame: Up to last follow-up
Recurrence rate
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial
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Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Françoise SCHMITT principal investigator
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Sacrococcygeal Pilonidal Sinus, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Françoise SCHMITT (0241353637 ext. +33, FrSchmitt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.