| CTRI Number |
CTRI/2024/02/063215 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Use of three ring vulvoscopy in patients with vulval disease |
|
Scientific Title of Study
|
Determination of clinical utility of Three ring vulvoscopy (TRIV) for detection of vulval pathologies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. TANUJA SHARMA |
| Designation |
Junior Resident |
| Affiliation |
post graduate institute of medical education and research Chandigarh |
| Address |
Department of Obstetrics and gynaecology
post graduate institute of medical education and research Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9418984215 |
| Fax |
|
| Email |
sharmatanuja206@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bharti Joshi |
| Designation |
assistant professor |
| Affiliation |
post graduate institute of medical education and research |
| Address |
Department of Obstetrics and gynaecology
post graduate institute of medical education and research Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9915166210 |
| Fax |
|
| Email |
drbhartijoshi09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Bharti Joshi |
| Designation |
assistant professor |
| Affiliation |
post graduate institute of medical education and research |
| Address |
Department of Obstetrics and gynaecology
post graduate institute of medical education and research Chandigarh
CHANDIGARH 160012 India |
| Phone |
9915166210 |
| Fax |
|
| Email |
drbhartijoshi09@gmail.com |
|
|
Source of Monetary or Material Support
|
| post graduate institute of medical education and research |
|
|
Primary Sponsor
|
| Name |
post graduate institute of medical education and research |
| Address |
post graduate institute of medical education and research Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanuja Sharma |
post graduate institute of medical and research Chandigarh |
Room no. 2050 minor OT 2nd floor
New Gynae OPD Pgimer Chandigarh CHANDIGARH |
9418984215
sharmatanuja206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| post graduate institute of medical and research Chandigarh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers |
| Patients |
(1) ICD-10 Condition: R876||Abnormal cytological findings in specimens from female genital organs, (2) ICD-10 Condition: N90||Other noninflammatory disorders ofvulva and perineum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
naked eye examination |
Symptomatic women with any vulval symptoms (chronic or recurrent vulval, visible vulval lesions, any abnormal skin changes or whitening or hardening
of the vulvar skin. Cervical smear examination is negative for intra epithelial lesions or malignancy will be examined by naked eye |
| Intervention |
three ring vulvoscopy |
Symptomatic women with any vulval symptoms (chronic or recurrent vulval, visible vulval lesions, any abnormal skin changes or whitening or hardening
of the vulvar skin. Cervical smear examination is negative for intra epithelial lesions or malignancy.will be examined by three ring vulvoscopy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
age more than 18 years
women with any vulval complaints
women with abnormal findings on routine examination
women diagnosed with HSIL |
|
| ExclusionCriteria |
| Details |
antennal woman
active malignancy under chemoradiation
post chemo radiation
active genital lesions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the TRIV for diagnosis of various vulval pathologies in different study groups with unaided examination |
To compare the TRIV for diagnosis of various vulval pathologies in different study groups with unaided examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find prevalence of various vulval pathologies in different study group |
After completion of study, i.e. after 1 year |
| to find best biopsy location with TRIV in woman with abnormal vulval findings |
at same time during vulvoscopy same day |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. “Psoriasis, 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 | of the vulvar skin. Cervical smear examination is negative for intra epithelial lesions or malignancy.  | 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.  |
 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. |