Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 7:08 AM
Study NCT ID:
NCT06021392
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of recurrence', 'timeFrame': 'In about 6 month follow up', 'description': 'Showing each of both procedures efficacy in decreasing rate of recurrence of PNS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'Comparative study between wide local excision and minimal excision of pilonidal sinus', 'detailedDescription': "Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy with maximum productivity. Wide local excision creates a tissue gap, while the concept of minimal excision preserves healthy tissues with minimal tissue gap.\n\nPilonidal disease is a frequent suppurative condition that occurs twice as often in men as in women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin of the sacro-coccygeal region. It presents acutely as an abscess under tension while the chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is clinical and usually straightforward. In the large majority of cases, treatment is surgical but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an off-midline incision seems preferable. Excision is the standard definitive treatment but the choice of wide versus limited excision on the school of thought. Minimal excision or debridement of the sinus and/or cavity through a midline or a separate paramedian excision can also be performed, leaving the wounds open or closed. These methods are simple and cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal activity. A disadvantage is the higher recurrence rate; however, these methods can be used repeatedly for recurrences. Although recurrence rates seem high at first glance, the procedures can be successfully repeated for recurrences, achieving healing rates of over 90% for 1-2 interventions. Future well-designed trials are necessary to aid patient selection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy people of both genders with or without history of PNS procedures before', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients complaining of primary PNS and Recurrent PNS following Minimal excision\n\nExclusion Criteria:\n\n* Recurrent PNS following wide local excision'}, 'identificationModule': {'nctId': 'NCT06021392', 'briefTitle': 'Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus', 'orgStudyIdInfo': {'id': 'Techniques of PNS excision'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wide local excision of pilonidal sinus', 'interventionNames': ['Procedure: Z plasty and minimal excision of pilonidal sinus']}, {'label': 'Minimal excision of pilonidal sinus', 'interventionNames': ['Procedure: Z plasty and minimal excision of pilonidal sinus']}], 'interventions': [{'name': 'Z plasty and minimal excision of pilonidal sinus', 'type': 'PROCEDURE', 'description': 'The investigators will perform a " Z plasty " procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures', 'armGroupLabels': ['Minimal excision of pilonidal sinus', 'Wide local excision of pilonidal sinus']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abanoub emad fayez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident doctor in Assiut university hospitals', 'investigatorFullName': 'Abanoub emad fayez', 'investigatorAffiliation': 'Assiut University'}}}}