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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05988151
Other study ID # 2022/25
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2022
Est. completion date August 2, 2023

Study information

Verified date October 2023
Source Batman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. No history of any disease 2. The presence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear. 3. Body mass index between 15-25 4. Informed consent has been obtained for the new surgical approach technique. 5. Not taking any medication continuously 6. Willing to participate in the study. Exclusion Criteria: 1. Absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear. 2. History of continuous medication, alcohol and/or smoking. 3. History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric disease etc.) 4. Body mass index outside the range of 15-25. 5. Not wanting to be included in the study or wanting to leave the study after inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
New surgical approach
Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.

Locations

Country Name City State
Turkey Batman Training and Research Hospital Batman

Sponsors (1)

Lead Sponsor Collaborator
Batman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary To be able to standardize genital harmony using fibonacci ratio. 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). Postoperative 1 month
Secondary To adapt the fibonacci ratio to female genital cosmetic surgery To adapt the fibonacci ratio applied in breast and facial aesthetics to female genital aesthetic surgery procedures. Postoperative 1 month
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