Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-29 @ 10:45 PM
Study NCT ID:
NCT05569135
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2022-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease recurrence at 36 months', 'timeFrame': '36 months', 'description': 'Any ongoing or recurrent sypmtoms were recorded'}], 'secondaryOutcomes': [{'measure': 'Complications after the procedure', 'timeFrame': '1 month', 'description': 'Safety of the procedure'}, {'measure': 'Incidence of adverse events', 'timeFrame': '1 month', 'description': 'Safety of the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pilonidal Disease']}, 'referencesModule': {'references': [{'pmid': '17573759', 'type': 'BACKGROUND', 'citation': 'Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis. 2007 Jul;9(6):575-6. doi: 10.1111/j.1463-1318.2007.01236.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).\n\nData of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and males older than 18 years old', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification\n* Patients who underwent debridement for pilonidal disease\n\nExclusion Criteria:\n\n* Patients with acute abscess (Tezel Class II)\n* Antibiotic use within 4 weeks before surgery\n* Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months'}, 'identificationModule': {'nctId': 'NCT05569135', 'briefTitle': 'Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-2926'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Debridement only', 'description': 'Debridement of the pilonidal cyst through pits was performed in this group. After the removal of hair and necrotic tissues through pits, the surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery.'}, {'label': 'Debridiment with laser ablation', 'description': 'This group underwent the same procedure as the debridement group. After the removal of hair and necrotic tissues through pits, a diode laser at 1470 wavelength was inserted and the pilonidal cavity was ablated in a continuous fashion. The surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery.', 'interventionNames': ['Device: Laser ablation']}], 'interventions': [{'name': 'Laser ablation', 'type': 'DEVICE', 'description': 'A diode-laser that has been reported to be safe and effective in several treatments including pilonidal disease, anal fistula, hemorrhoids, and vascular ablation was used to obtain shrinkage of pilonidal cyst', 'armGroupLabels': ['Debridiment with laser ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34196', 'city': 'Istanbul', 'state': 'Other (Non U.s.)', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol Bahcelievler Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Naciye Cigdem Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}