Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
Study NCT ID:
NCT04356768
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2020-04-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1971}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidental cancer', 'timeFrame': '2 or 3 week', 'description': 'Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilonidal sinus', 'carcinoma', 'pathology', 'squamous cell carcinoma', 'phenol'], 'conditions': ['Pathology']}, 'descriptionModule': {'briefSummary': 'Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; We think that routine pathological examination of the pilonidal sinus is unnecessary.', 'detailedDescription': 'Pilonidal sinus is a benign disease. In the histopathological examination of pilonidal sinus specimens, malignancy can be detected rarely. Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. The investigators aimed to discuss the pathological findings of patients who were operated for pilonidal sinus in our clinic in light of the literature. The fact that the rate of malignancy in the literature does not show parallelism with minimally invasive procedures that pathology samples are not taken and whose applications are increasing supports this prediction. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; the investigators think that routine pathological examination of the pilonidal sinus is unnecessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were operated on for pilonidal sinus between January 2016 and March 2020 at our hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sacrococcygeal pilonidal sinus\n\nExclusion Criteria:\n\n* non-sacrococcygeal pilonidal sinus\n* minimally invasive treatment without histopathological examination'}, 'identificationModule': {'nctId': 'NCT04356768', 'briefTitle': 'Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Ersin Arslan Education and Training Hospital'}, 'officialTitle': 'Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens, Retrospective Analysis of 1971 Resections.', 'orgStudyIdInfo': {'id': '17042020'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Ersin Arslan Training and Resource Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'Ufuk Uylas, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Ersin Arslan Training and Resource Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Ersin Arslan Education and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Ufuk Uylas', 'investigatorAffiliation': 'Dr. Ersin Arslan Education and Training Hospital'}}}}