Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201709002544183 Date of Approval: 24/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Aesthetic Assessment of External Female Genital System and Its Impact on Quality of Life
Official scientific title Aesthetic Assessment of External Female Genital System and Its Impact on Quality of Life
Brief summary describing the background and objectives of the trial During the last few years female genital plastic surgery has become very popular. Nowadays it is more common to see sexual images in magazines, videos, and television. The world has become more open to sexuality. Women can now compare themselves, see how others look, and decide if their genital appearance is acceptable or not. If they are not happy with their look, they can seek surgical intervention; this is why female genitoplasty procedures have increased 20 % annually over the last few years. Most women are relieved when they find out that a single procedure can resolve their physical and sexual distress. However, female genital plastic surgery is not completely accepted because even though women enjoy equal opportunities with men in many areas, our society tends to negatively judge women who want to enjoy the full expression of their sexuality. We as doctors must provide our patients with alternatives for their sexual and physical well-being: Female genitoplasty achieves this purpose.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Morphological abnormalities of female external genitalia, Female Sexual dysfunction,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date 01/10/2019
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Examination and Parameter measurements Each case to be examined for any morphological abnormalities in the external Genitalia with parameters measurements in addition to assessment of Female Sexual dysfunction and if those morphological abnormalities are causing any dysfunction. 200
Control Group Female Sexual Function Index Each female will be asked questions about her sexual feelings and responses during the past 4 weeks regarding sexual activity, intercourse and stimulation and the results will be evaluated through FSFI Domain Scores and Full Scale Scores sheet 200
Control Group Parameters measurements of Female External Genitalia External Female Genital System to be examined for Parameters measurements through examination during a] Standing Erect position to examine the parameters of Mons Pubis and whether Labia Minora is protruding past Labia Majora or no and b] Lithotomy position to measure the parameters of Labia Minora, Labia Majora, Clitoral Hood, Vagina and Perineum and Degree of mutilation according to WHO. 200
Control Group Female Sexual Distress Scale The scale is a list of feelings and problems that men and women sometimes have concerning their sexuality. Each female should check the box that best describes how often that problem has bothered her or caused distress over the last 4 weeks. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Female - Egyptian - Age: 18 years old till menopause - Age less than 18 years old - Females after menopause - Any morphological abnormality on top of current pathological disease. (ex. Cancer cervix, Vaginal prolapse, Genital warts, etc.) 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/08/2017 Faculty of Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine-Assiut University Assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of Female External Genitalia morphological abnormalities and its impact on Female Sexual Dysfunction and self body image. Immediately after examination of the patient.
Secondary Outcome Recommendation of possible surgical procedures to enhance the female's self body image and thus fixing sexual dysfunction resulting from it. Immediately after examination of the female and consultation of Plastic Surgery Consultant.
Secondary Outcome Standard measurements for female external genitalia in 2 positions Standing erect and Lithotomy. Immediately during the examination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Hospital Assiut University Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Plastic and Reconstructive Surgery Department Assiut University Hospital Assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Plastic and Reconstructive Surgery Department Assiut University Hospital Assiut 71111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Plastic and Reconstructive Surgery Department Assiut University Hospital Assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Mohamed dremanahmed83@gmail.com +201006971990 Al Mabarra Health Insurance Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Plastic Surgery Resident
Role Name Email Phone Street address
Public Enquiries Usama Taha usama.taha@med.au.edu.eg +201069468684 Plastic Surgery Dept. Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Assistant Professor of Plastic Surgery
Role Name Email Phone Street address
Scientific Enquiries Assem Hussein assemk88@aun.edu.eg +201005319242 Plastic Surgery Dept. Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Professor of Plastic Surgery
REPORTING
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