Gynecologic DiseaseNCT05988151
New Surgical Approach in Labioplasty
An observational study of Gynecologic Disease and Surgery-Complications, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease, Surgery-Complications
- What is being tested?
- New surgical approach
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2022to 2 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who underwent labioplasty plus vajinoplasti prosedures in our clinic (age 18-45 years old)
Who may be able to join
- 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.
Who cannot join
- 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 15-25.
- Not wanting to be included in the study or wanting to leave the study after inclusion.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Training and Research Hospital
Batman, 72000
About this study
Official title: New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio
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.
- Conditions
- Gynecologic Disease, Surgery-Complications
- Being tested
- New surgical approach
- Keywords
- Labioplasty, Vaginoplasty, Fibonacci ratio
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New surgical approachOther
Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.
| Study group | Role | What they receive |
|---|---|---|
| New surgical approach (Fibonacci ratio) | Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio. Receives: Other: New surgical approach | |
| Classical surgical approach (control group) | A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Apr 2022
- Primary completion1 Jul 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
- Investigators
- Erhan Okuyan, Principal investigator, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988151
- Sponsor's protocol ID
- 2022/25
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share after publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio
- ClinicalTrials.gov ID
- NCT05988151
- Acronym / sponsor ID
- 2022/25
- Conditions
- Gynecologic Disease, Surgery-Complications
- Keywords
- Labioplasty, Vaginoplasty, Fibonacci ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New surgical approach (Fibonacci ratio) | – | Other: New surgical approachAgroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio. |
| Classical surgical approach (control group) | – | –A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who underwent labioplasty plus vajinoplasti prosedures in our clinic (age 18-45 years old)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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 15-25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New surgical approachPatients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio. | Other | New surgical approach (Fibonacci ratio) |
Primary outcome
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).
1 secondary outcome
To adapt the fibonacci ratio to female genital cosmetic surgery
Time frame: Postoperative 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No. Share after publication
Related trials for Gynecologic Disease
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Okuyan principal investigator
Batman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease and Surgery-Complications, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To be able to standardize genital harmony using fibonacci ratio. (time frame: Postoperative 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.