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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure rate', 'timeFrame': '2 months after surgery', 'description': 'Definition of failure:\n\n* Absence of complete wound healing at 2 months, OR\n* Clinical recurrence of pilonidal sinus within 2 months'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Up to 1 year', 'description': '* Early (\\<30 days) and late complications\n* Graded according to Clavien-Madadi classification Through study completion, average 6 month'}, {'measure': 'Time to complete wound healing', 'timeFrame': 'Up to 1 year', 'description': 'time in months'}, {'measure': 'Length of hospital stay', 'timeFrame': 'at hospital discharge', 'description': 'duration of hospital stay in days'}, {'measure': 'Postoperative pain duration', 'timeFrame': 'Up to 30 days'}, {'measure': 'Postoperative pain Intensity', 'timeFrame': 'Up to 30 days'}, {'measure': 'Analgesic consumption for postoperative pain', 'timeFrame': 'Up to 30 days', 'description': 'morphine equivalent dose'}, {'measure': 'Predictive factors for recurrence', 'timeFrame': 'Up to last follow-up', 'description': 'bivariate and multivariate analysis'}, {'measure': 'Recurrence rate', 'timeFrame': 'Up to 1 year', 'description': 'Through study completion, average 6 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilonidal sinus', 'Pediatric surgery', 'Recurrence', 'Wound healing', 'Surgical outcomes'], 'conditions': ['Sacrococcygeal Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.\n\nResults are expected to help optimize institutional management strategies and contribute to pediatric-specific evidence.', 'detailedDescription': 'This is a single-center retrospective observational cohort study conducted in the Departments of Pediatric Surgery and Visceral Surgery at CHU Angers, France.\n\nAll 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.\n\nSurgical techniques analyzed include:\n\n* Wide excision with open healing\n* Wide excision with primary midline closure\n* Wide excision with primary midline closure and negative pressure wound therapy\n* 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.\n\nData will be extracted from medical records and anonymized prior to statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18 years at time of surgery\n* Surgical treatment for pilonidal sinus disease\n* Surgery performed between January 1, 2015 and March 31, 2025\n* Managed at CHU Angers (Pediatric or Visceral Surgery departments)\n* ICD-10 diagnosis code L05.9\n* CCAM procedure code QBFA007\n\nExclusion Criteria:\n\n* Emergency incision and drainage of acute pilonidal abscess (CCAM QBPA001)\n* Initial surgical management performed at another institution\n* Refusal of participation (patient and/or legal guardians, if applicable)\n* Alternative diagnosis (anal abscess, gluteal abscess)'}, 'identificationModule': {'nctId': 'NCT07470294', 'acronym': 'PiloPedia', 'briefTitle': 'Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '49RC25_0350'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wide excision with open healing', 'description': '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.', 'interventionNames': ['Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.']}, {'label': 'Wide excision with primary midline closure', 'description': 'Alternative technique using an immediate closure of the wound with layer of stiches, and regular dressings', 'interventionNames': ['Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.']}, {'label': 'Wide excision with primary midline closure and negative pressure wound therapy', 'description': '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.', 'interventionNames': ['Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.']}, {'label': 'Minimally invasive/endoscopic techniques', 'description': 'Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.', 'interventionNames': ['Procedure: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.']}], 'interventions': [{'name': 'Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Françoise SCHMITT', 'role': 'CONTACT', 'email': 'FrSchmitt@chu-angers.fr', 'phone': '0241353637', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Françoise SCHMITT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}