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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 complaintsMost 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

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.

 
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