New Surgical Approach in Labioplasty

NCT05988151 | Completed

• 1 other identifier: 2022/25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Disease; Surgery-Complications

Keywords

Labioplasty; Vaginoplasty; Fibonacci ratio

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To adapt the fibonacci ratio to female genital cosmetic surgery

  Postoperative 1 month

Study Arms (2)

New surgical approach (Fibonacci ratio)

Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio.

Other: New surgical approach

Classical surgical approach (control group)

A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.

Interventions

New surgical approach OTHER

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

New surgical approach (Fibonacci ratio)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• No history of any disease
• The presence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear.
• Body mass index between 15-25
• Informed consent has been obtained for the new surgical approach technique.
• Not taking any medication continuously
• Willing to participate in the study.

You may not qualify if:

• Absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal
• abundance, personal hygiene disorder, difficulty in wearing underwear.
• History of continuous medication, alcohol and/or smoking.
• History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric disease etc.)
• Body mass index outside the range of 15-25.

Sponsors & Collaborators

• Batman Training and Research Hospital: lead

Study Sites (1)

Batman Training and Research Hospital

Batman, 72000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Erhan Okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D Obstetrics and Gynecology specialist

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: April 12, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 2, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)