New Surgical Approach in Labioplasty

NCT ID: NCT05988151

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-12

Study Completion Date

2023-08-02

Brief Summary

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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

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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.

Conditions

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Gynecologic Disease Surgery-Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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New surgical approach (Fibonacci ratio)

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

New surgical approach

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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New surgical approach

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Batman Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erhan Okuyan,M.D

M.D Obstetrics and Gynecology specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erhan Okuyan

Role: PRINCIPAL_INVESTIGATOR

Batman Training and Research Hospital

Locations

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Batman Training and Research Hospital

Batman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022/25

Identifier Type: -

Identifier Source: org_study_id

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