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CompletedNCT05988151Updated Oct 17, 2023

New Surgical Approach in Labioplasty

An observational study in Gynecologic Disease and Surgery-Complications, sponsored by Batman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Batman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Gynecologic Disease
  • Surgery-Complications

Keywords

  • Labioplasty
  • Vaginoplasty
  • Fibonacci ratio
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In context

Genital Diseases, Female

154 studies on the registry are indexed under Genital Diseases, Female; 32 are open to participants now.

This study's enrollment of 100 is below the median of 153 across 39 observational studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

Batman Training and Research Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNew surgical approach

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

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What researchers measure

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).

    Time frame: Postoperative 1 month

Secondary outcomes

  1. To adapt the fibonacci ratio to female genital cosmetic surgery

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

    Time frame: Postoperative 1 month

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Study locations

1 site
  • Batman Training and Research Hospital
    Batman, 72000, Turkey
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References and documents

Individual participant data

Plan to share: No — Share after publication

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05988151
Lead sponsor
Batman Training and Research Hospital
Responsible party
Erhan Okuyan,M.D (M.D Obstetrics and Gynecology specialist, Batman Training and Research Hospital) — Principal investigator
First posted
Aug 14, 2023
Start date
Apr 12, 2022
Primary completion
Jul 1, 2023
Completion
Aug 2, 2023
Last update
Oct 17, 2023

Study contacts

Erhan Okuyan
principal investigator · Batman Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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