Determination of clinical utility of Three ring vulvoscopy (TRIV) for detection of vulval pathologies

Vulva is the outer part of female genitalia which includes mons pubis, labia majora and minora, vestibular bulbs, clitoris, vestibule, skene’s glands, bartholin’s glands, urethra and vaginal opening.The overall prevalence of vulvar diseases in the literature is low because of underreporting and is often neglected. The prevalence of vulvar diseases has been reported as

or all of the vulva, causing vulval discomfort. It can affect any age group. According to ISSVD (International Society for the study of vulvovaginal disease) 2011 classification based on color of vulval lesions, vulval diseases consist of hypopigmentation disease, vulval infections, benign and malignant tumors. As indicated from the epidemiological investigation, the malignant change rate ranges from 2% ~ 5%, which increases with age. Vulval dermatosis is a common vulval inflammatory disorder. It is responsible for 33-50% of vulval complaints. Most common symptom is pruritus, which has a negative effect on the quality of life. Mainly, there are six common types of vulval dermatosis. â€œPsoriasis, lichen sclerosis, lichen simplex chronicus and lichen planus, plasma cell vulvitis and desquamative inflammatory vaginitis. LS (lichen sclerosis) can advance to facultative precancerous lesions of squamous cell carcinoma. Females with sclerosing lichen are subject to a 2% to 5% risk of vulva cancer. 5,6 Vulval hypopigmentation refers to a group of common and refractory skin diseases with pruritus as the main symptom, which is primarily characterized by hypopigmentation of vulva skin. Vulval infections includes vulvovaginal candidiasis, genital herpes, genital warts, HPV infection, taenia cruris. Vulvar tumours include benign tumours, squamous intraepithelial lesions and malignant tumours. Over the past few decades, the overall incidence of vulvar cancer has been elevated by 4.6% every 5 years on average.

Most common clinical manifestations of vulval diseases are pruritis, vulval pain and leucoplakia. Woman may also present with change in vulval skin colour like erythema or excoriation, ulcers, lichenification of vulval skin.

Diagnosis is based on a detailed history with thorough examination of vulva including the perianal area followed by vulvoscopic examination. Gold standard is histopathological examination of affected area.This three arm interventional study will be conducted in the department of Obstetrics and Gynecology, PGIMER Chandigarh. All women attending the Gynecology OPD of PGIMER will be invited to participate in the study. They will be further enrolled if willing to participate and recruited after fulfilling the eligibility criteria. A thorough and detailed history will be taken followed by general and local examination of the vulva, and a working clinical diagnosis will be made which will be confirmed by a senior resident.

Eligible women will be recruited into respective groups after obtaining written informed consent.

Based on the working clinical diagnosis, women will be divided in to three groups

Group I- Symptomatic women with any vulval symptoms (chronic or recurrent vulval, visible vulval lesions, any abnormal skin changes or whitening or hardening

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of the vulvar skin. Cervical smear examination is negative for intra epithelial lesions or malignancy.

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Group II- Asymptomatic women with normal unaided vulval examination Cervical smear examination is negative for intra epithelial lesions or malignancy. Group III- Women having or treated for HSIL of cervix (on HPE), details will be taken from Pathology department of PGIMER.

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All the three groups will undergo TRIV. The women will be placed in lithotomy position. The examination of vulva will be performed by colposcope under low magnification (i.e. 6x magnification later proceeding to higher if needed) in a systemic manner including mons pubis, labia majora and minora, clitoris and perineum. The critical evaluation of any lesion if found will be done. Vulva will be examined under magnification after applying 5 % acetic acid for 3-5 minutes using- soaked gauze pad as keratinized skin of vulva requires longer application, and will be visualized using lowest i.e. 6x magnification later proceeding to higher if needed. An eczematous inflammation with thickened, excoriated skin (red, flat, and diffuse lesions presenting on the vulvar skin); hypopigmented or white lesions (irregularly and extensively diffuse white plaques and patches on skin and mucosa); white reticular pattern to extensive erosion especially in the vestibule; erythematous

papules with silver, scaly plaques, agglutination and fusion; or resorption of the

labia minora and clitoral hood, loss of vulvar architecture, and sclerotic changes

will be considered as abnormal. The abnormal lesions will be categorized based on the location in the vulva according to the 3 zones/ rings. Vulvoscopy index will be calculated and patient will be divided in to 5 categories based on vulvoscopy index.