New Surgical Approach in Labioplasty

• Sponsor: Batman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05988151
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease; Surgery-Complications	Other: New surgical approach	N/A

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 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: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients who gave informed consent preoperatively and accepted the surgical technique using the fibonacci ratio approach and patients who underwent the classical surgical technique were divided into 2 groups.Patients who gave informed consent preoperatively and accepted the surgical technique using the fibonacci ratio approach and patients who underwent the classical surgical technique were divided into 2 groups.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio
• Actual Study Start Date: Mar 12, 2022
• Actual Primary Completion Date: Jul 1, 2023
• Actual Study Completion Date: Aug 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.
No Intervention: Classical surgical approach (control group) A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.

Outcome Measures

Primary Outcome Measures

1. To be able to standardize genital harmony using fibonacci ratio. [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 Outcome Measures

1. To adapt the fibonacci ratio to female genital cosmetic surgery [Postoperative 1 month]

   To adapt the fibonacci ratio applied in breast and facial aesthetics to female genital aesthetic surgery procedures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

1. History of continuous medication, alcohol and/or smoking.

2. History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric disease etc.)

3. Body mass index outside the range of 15-25.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Batman Training and Research Hospital	Batman		Turkey	72000

Sponsors and Collaborators

• Batman Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erhan Okuyan,M.D, M.D Obstetrics and Gynecology specialist, Batman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05988151
• Other Study ID Numbers: 2022/25
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Erhan Okuyan,M.D, M.D Obstetrics and Gynecology specialist, Batman Training and Research Hospital: Labioplasty; Vaginoplasty; Fibonacci ratio
• Additional relevant MeSH terms: Genital Diseases, Female

Study Results

No Results Posted as of Aug 14, 2023