| CTRI Number |
CTRI/2025/03/082401 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of cryotherapy on cervical ectropion |
|
Scientific Title of Study
|
Effectiveness of cryotherapy for symptomatic cervical ectropion |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailaja R Bidri |
| Designation |
Professor,HOD of OBG |
| Affiliation |
Shri BM Patil Medical College And hospital |
| Address |
Shri BM Patil medical college hospital,bangaramma sajjan campus,vijayapura
Shri BM Patil medical college an d hospital,bangaramma sajjan campus,vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9880162550 |
| Fax |
|
| Email |
drsrbidri1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja R Bidri |
| Designation |
Professor and HOD of OBG |
| Affiliation |
Shri BM Patil Medical College And hospital |
| Address |
Shri BM Patil medical college,hospital,bangaramma sajjan campus,vijayapura
Shri BM Patil medical college an d hospital,bangaramma sajjan campus,vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9880162550 |
| Fax |
|
| Email |
drsrbidri1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja R Bidri |
| Designation |
Professor and HOD of OBG |
| Affiliation |
Shri BM Patil Medical College And hospital |
| Address |
OBG OPD NO 2,Shri BM Patil medical college and hospital , bangaramma sajjan campus , vijayapura
OBG OPD NO2,Shri BM Patil medical college an d hospital,bangaramma sajjan campus,vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9880162550 |
| Fax |
|
| Email |
drsrbidri1@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI BM Patil medical college and hospital;Research Centre Smt Bangaramma Sajjan Campus Solapur road,vijayapura 586103 |
|
|
Primary Sponsor
|
| Name |
SHRI BM PATIL MEDICAL COLLEGE |
| Address |
OBG OPD no2,Shri BM Patil medical college hospital and research centre bangaramma sajjan campus,Vijayapura,586103 |
| 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 Sravya |
Shri BM Patil medical college hospital and research centre |
Solapur road, Bangaramma sajjan campus
Bijapur
KARNATAKA |
8309108736
bezawadashravya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EFFECTIVENESS OF CRYOTHERAPY ON CERVICAL ECTROPION |
PATIENTS COMING WITH COMPLAINTS OF VAGINAL DISCHARGE,VULVO VAGINAL DISCOMFORT,DYSPAREUNIA CRYOTHERAPY WILL BE DONE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
MARRIED WOMAN BETWEEN 25-40YEARS OF AGE GROOUP WITH VAGINAL DISCHARGE/VULVOVAGINAL DISCOMFORT/DYSPAREUNIA |
|
| ExclusionCriteria |
| Details |
ACTIVE GENITALTRACT INFECTION OR SUSPECTED CARCINOMA CERVIX |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the impact of cryotherapy on cervical ectropion in reduction of vaginal discharge, vulvovaginal discomfort , dyspareunia.
Â
|
To know the impact of cryotherapy on cervical ectropion in reduction of vaginal discharge, vulvovaginal discomfort , dyspareunia.
Â
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of cryotherapy in making patient symptom free and reducing its recurrence.
Â
|
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cervical ectropion is benign condition, mostly seen in reproductive age group. It may be silent or asymptomatic, if present its mostly associated with leucorrhea, post coital bleeding. Other features like pelvic pain, dyspareunia, usually found on routine pelvic examination. Cervical ectropion is of two types one related to increased estrogen levels and the other is congenital. Cervix is responsive to estrogen, causing proliferation and differentiation of cervical epithelium, hence its mostly seen in the adolescents, pregnancy, women on OCP, menstrual phase i.e., ovulatory phase. Cervical cauterization is a low-cost technique and easily accessible procedure for treatment of cervical ectropion. It’s a procedure in which cautery probe is kept against ectropion for 2mins and frozen. After treatment there is reduction in symptoms. There are few side effects and, but patient satisfaction is high. It helps in preserving the fertility of woman at the same time addressing vaginal discharge. PURPOSE: TO KNOW THE EFFECTIVENESS OF CRYOTHERAPY ON CERVICAL ECTROPION |