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Clinical Trials/NCT05988151
NCT05988151CompletedNot Applicable

New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio

Batman Training and Research Hospital1 site in 1 country100 target enrollmentStarted: April 12, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
To be able to standardize genital harmony using fibonacci ratio.

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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-
  • Not wanting to be included in the study or wanting to leave the study after inclusion.

Outcomes

Primary Outcomes

To be able to standardize genital harmony using fibonacci ratio.

Time Frame: Postoperative 1 month

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).

Secondary Outcomes

  • To adapt the fibonacci ratio to female genital cosmetic surgery(Postoperative 1 month)

Investigators

Sponsor
Batman Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Erhan Okuyan,M.D

M.D Obstetrics and Gynecology specialist

Batman Training and Research Hospital

Study Sites (1)

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