Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05988151
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Surgical Approach in Labioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-14', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To be able to standardize genital harmony using fibonacci ratio.', 'timeFrame': 'Postoperative 1 month', 'description': 'To standardize the genital harmony with a holistic approach with the Fibonacci ratio with a purely mathematical ratio outside the existing classification systems (in contrast to Banwell, Motakeff classifications).'}], 'secondaryOutcomes': [{'measure': 'To adapt the fibonacci ratio to female genital cosmetic surgery', 'timeFrame': 'Postoperative 1 month', 'description': 'To adapt the fibonacci ratio applied in breast and facial aesthetics to female genital aesthetic surgery procedures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labioplasty', 'Vaginoplasty', 'Fibonacci ratio'], 'conditions': ['Gynecologic Disease', 'Surgery-Complications']}, 'descriptionModule': {'briefSummary': 'The data of patients who underwent labiaplasty + vaginoplasty between 2020 and 2022 by a single surgeon in our clinic were analyzed. Preoperative and postoperative FSFI (Female sexual function index) questionnaire scores were used to compare the results of the classical surgical approach and the new surgical approach technique designed according to the Fibonacci ratio in the early postoperative period such as operating time, bleeding amount, etc.', 'detailedDescription': 'The data of patients who underwent labiaplasty + vaginoplasty between 2020-2022 for reasons such as vaginal laxity, personal hygiene problems, recurrent vaginal infections were analyzed retrospectively. The data of the patients who underwent fibonacci ratio, which is a new surgical approach technique( by Okuyan E. M.D), and the patients who underwent classical surgical technique were taken from their files and retrospectively analyzed. Data including age, body mass index, number of live births, preoperative FSFI, FGSIS and postoperative one month FSFI (Female sexual function index) and FGSIS (The Female Genital Self-Image Scale) scores were recorded and compared between both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent labioplasty plus vajinoplasti prosedures in our clinic (age 18-45 years old)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. No history of any disease\n2. The presence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear.\n3. Body mass index between 15-25\n4. Informed consent has been obtained for the new surgical approach technique.\n5. Not taking any medication continuously\n6. Willing to participate in the study.\n\nExclusion Criteria:\n\n1. Absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal\n\n abundance, personal hygiene disorder, difficulty in wearing underwear.\n2. History of continuous medication, alcohol and/or smoking.\n3. History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric disease etc.)\n4. Body mass index outside the range of 15-25.\n5. Not wanting to be included in the study or wanting to leave the study after inclusion.'}, 'identificationModule': {'nctId': 'NCT05988151', 'briefTitle': 'New Surgical Approach in Labioplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Batman Training and Research Hospital'}, 'officialTitle': 'New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio', 'orgStudyIdInfo': {'id': '2022/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New surgical approach (Fibonacci ratio)', 'description': 'Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio.', 'interventionNames': ['Other: New surgical approach']}, {'label': 'Classical surgical approach (control group)', 'description': 'A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.'}], 'interventions': [{'name': 'New surgical approach', 'type': 'OTHER', 'description': 'Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.', 'armGroupLabels': ['New surgical approach (Fibonacci ratio)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Batman', 'country': 'Turkey (Türkiye)', 'facility': 'Batman Training and Research Hospital', 'geoPoint': {'lat': 37.88738, 'lon': 41.13221}}], 'overallOfficials': [{'name': 'Erhan Okuyan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Batman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Share after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Batman Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D Obstetrics and Gynecology specialist', 'investigatorFullName': 'Erhan Okuyan,M.D', 'investigatorAffiliation': 'Batman Training and Research Hospital'}}}}