Clinical trial NCT05988151: New Surgical Approach in Labioplasty
Official title: New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Surgery-Complications
Keywords: Labioplasty
Vaginoplasty
Fibonacci ratio
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent labioplasty plus vajinoplasti prosedures in our clinic (age 18-45 years old)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To be able to standardize genital harmony using fibonacci ratio.
timeFrame: Postoperative 1 month
Secondary outcomes:
measure: To adapt the fibonacci ratio to female genital cosmetic surgery
timeFrame: Postoperative 1 month
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Training and Research Hospital
Study officials:
affiliation: Batman Training and Research Hospital
name: Erhan Okuyan
role: PRINCIPAL_INVESTIGATOR
References: