Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 7:28 PM
Study NCT ID:
NCT05519033
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilonidal Sinus-Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1742}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Recurrence', 'timeFrame': '12 months', 'description': 'Determine the postoperative recurrence rates according to type of surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'the ratio of different techniques methods', 'timeFrame': '12 months', 'description': 'Compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pilonidal Sinus Treatment']}, 'descriptionModule': {'briefSummary': 'In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. .\n\nPrimary outcome; To determine the postoperative recurrence rates according to the type of surgical intervention.\n\nThe secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.', 'detailedDescription': "In this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. The treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. Before collecting any patient data, the Lead Investigator or authorized research team member must be verified as suitable for the study.\n\nInformation should be processed on the Case Report Form (CRF) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. Collected participant data will be recorded in the relevant CRFs and patient questionnaires. You should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . As a result; Since all patients who were operated between January 2019 and January 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. Later, the data will be transferred and entered into RedCAP, a remote web-based data collection system.\n\nIn CRF, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ,with pilonidal sinus, treated by general surgeons', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician.\n\nExclusion Criteria:\n\n* Patients under 18 years of age asymptomatic (Stage I), acute abscess (Stage II), pregnant patients, presence of systemic disease such as DM, UC, Hidradenitis Suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.'}, 'identificationModule': {'nctId': 'NCT05519033', 'acronym': 'PiSi', 'briefTitle': 'Pilonidal Sinus-Turkey', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Pilondal Sinus Study: A National Survey', 'orgStudyIdInfo': {'id': 'PISI-TR'}}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Sezai Leventoglu, Proffesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ankara Oncology Research and Training Hospital', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ali Yalcinkaya', 'investigatorAffiliation': 'Gazi University'}}}}