New Surgical Approach in Labioplasty

Gynecologic Disease Clinical Trial

Official title:

New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988151
• Other study ID #: 2022/25
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

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