| CTRI Number |
CTRI/2024/07/071407 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Is three ring vulvoscopy better than conventional vulvoscopy for study of vulval diseases |
|
Scientific Title of Study
|
Comparison of conventional with three ring vulvoscopy for diagnosis of vulval disorders. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul kargwal |
| Designation |
Post graduate student |
| Affiliation |
VMMC and Safdarjung hospital new delhi |
| Address |
Department of obstetrics and gynaecology,ward no 03, Vmmc and Safdarjung hospital New Delhi
South
DELHI
110029
India |
| Phone |
7065528188 |
| Fax |
|
| Email |
parul19kargwl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sarita singh |
| Designation |
Associate professor and senior specialist |
| Affiliation |
Vmmc and Safdarjung hospital New Delhi |
| Address |
VMMC and Safdarjung hospital new delhi
South
DELHI
110029
India |
| Phone |
8826625892 |
| Fax |
|
| Email |
Saritadevina09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sarita singh |
| Designation |
Associate professor and senior specialist |
| Affiliation |
Vmmc and Safdarjung hospital New Delhi |
| Address |
Department of obstetrics and gynaecology, ward number 03,VMMC and Safdarjung hospital new delhi, 110029, India
South
DELHI
110029
India |
| Phone |
8826625892 |
| Fax |
|
| Email |
Saritadevina09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vmmc and Safdarjung hospital New Delhi , 110029, India |
|
|
Primary Sponsor
|
| Name |
Parul kargwal |
| Address |
Vmmc and Safdarjung hospital new dehi, 110029, India |
| Type of Sponsor |
Government medical college |
|
|
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 Parul kargwal |
Vmmc and Safdarjung Hospital, New Delhi |
Department of obstetrics and gynaecology,Vmmc and Safdarjung hospital new delhi,110029, India
South
DELHI |
7065528188
parul19kargwl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N909||Noninflammatory disorder of vulvaand perineum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All consecutive women presenting to OPD and admitted in ward with vulval complains of more than 3 months i.e. itching, pain, burning sensation, lesions, mass etc or requiring vulvoscopy for anyother indication. |
|
| ExclusionCriteria |
| Details |
Active vulval infections
Vulvovaginitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of conventional with three ring vulvoscopy for diagnosis of vulval disorders . |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the spectrum of vulval disease in three vulval zones |
1 year |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2024 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Vulvoscopy, the colposcopic examination of the vulva, is an essential part of an examinationof a woman who presents with vulvar discomfort. Vulvoscopy gives the examiner enhanced visualization of every part of the vulva, three ring method of examining the vulva is compared to conventional method of examining the vulva by randomized trials. |