New Surgical Approach in Labioplasty

New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease; Surgery-Complications
• Intervention / Treatment: Other: New surgical approach

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Batman, Turkey, 72000
    • Batman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent labioplasty plus vajinoplasti prosedures in our clinic (age 18-45 years old)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New surgical approach (Fibonacci ratio); Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio.	Other: New surgical approach; Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.
Classical surgical approach (control group); A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Batman Training and Research Hospital
• Investigators: Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Vaginoplasty; Labioplasty; Fibonacci ratio
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female
• Other Study ID Numbers: 2022/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No