Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT01583751
Status:
UNKNOWN
Last Update Posted:
2012-04-24
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videoendoscopic Pilonidal Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rates', 'timeFrame': 'six months', 'description': 'primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.'}], 'secondaryOutcomes': [{'measure': 'postoperative complications, wound healing', 'timeFrame': '1 month', 'description': 'Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pilonidal sinus', 'new technique', 'videoendoscopic'], 'conditions': ['Recurrence', 'Postoperative Complication']}, 'descriptionModule': {'briefSummary': 'This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.', 'detailedDescription': 'Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic pilonidal sinus disease\n* primer pilonidal sinus disease\n* noncomplicated pilonidal sinus disease\n\nExclusion Criteria:\n\n* Asymptomatic pilonidal sinus disease\n* Recurrence pilonidal sinus disease\n* complicated pilonidal sinus disease'}, 'identificationModule': {'nctId': 'NCT01583751', 'acronym': 'videosinus', 'briefTitle': 'Videoendoscopic Pilonidal Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'Videoendoscopic Pilonidal Sinus Surgery. A New Technique', 'orgStudyIdInfo': {'id': 'pilonidal1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'excision and primer repair surgical technique will be perform', 'interventionNames': ['Procedure: videoendoscopic resection of pilonidal sinus']}], 'interventions': [{'name': 'videoendoscopic resection of pilonidal sinus', 'type': 'PROCEDURE', 'otherNames': ['Active Comparator: Control: Group 1', 'Procedure/Surgery: Videoendoscopic: Group-2'], 'description': 'Resection of pilonidal sinus tissue with videoendoscopic approach.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34545', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'adnan yuksel, Prof', 'role': 'CONTACT', 'email': 'ayuksel@bezmialem.edu.tr', 'phone': '+902124531700'}, {'name': 'erhan aysan, assoc. prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'mahmut muslumanoglu, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'erhan aysan, assoc prof', 'role': 'CONTACT', 'email': 'dr@webcerrah.com', 'phone': '+904531700'}, {'name': 'adnan yukel, prof', 'role': 'CONTACT', 'email': 'ayuksel@bezmialem.edu.tr', 'phone': '+904531700'}], 'overallOfficials': [{'name': 'erhan aysan, assoc prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Erhan Aysan', 'investigatorAffiliation': 'SB Istanbul Education and Research Hospital'}}}}