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CTRI Number  CTRI/2023/10/059097 [Registered on: 25/10/2023] Trial Registered Prospectively
Last Modified On: 22/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two methods of treatment for persistent cervical discharge in patients 
Scientific Title of Study   Comparison of thermoablation with cryotherapy for the treatment of symptomatic cervical ectropion:A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HARBANI SONI 
Designation  POST GRADUATE RESIDENT DOCTOR 
Affiliation  Lady Hardinge Medical College 
Address  Department of obstetrics and gynaecology, Lady Hardinge Medical College,Connaught Place

New Delhi
DELHI
110001
India 
Phone  8130141234  
Fax    
Email  soniharbani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swati Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of obstetrics and gynaecology, Lady Hardinge Medical College, Connaught Place

New Delhi
DELHI
110001
India 
Phone  9810181964  
Fax    
Email  drswatilhmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  HARBANI SONI 
Designation  POST GRADUATE RESIDENT DOCTOR 
Affiliation  Lady Hardinge Medical College 
Address  Department of obstetrics and gynaecology, Lady Hardinge Medical College, Connaught Place

New Delhi
DELHI
110001
India 
Phone  8130141234  
Fax    
Email  soniharbani@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College 
 
Primary Sponsor  
Name  none 
Address  NA 
Type of Sponsor  Other [Non sponsored project] 
 
Details of Secondary Sponsor  
Name  Address 
NONE  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
HARBANI SONI  LADY HARDINGE MEDICAL COLLEGE  Department of obstetrics and gynaecology
New Delhi
DELHI 		 8130141234

soniharbani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LADY HARDINGE MEDICAL COLLEGE & ASSOCIATED HOSPITALS,SHAHEED BHAGAT SINGH MARG , NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  cryotherapy  Cryotherapy, is the most commonly used method to treat symptomatic cervical ectropion wherein the cryo-probe is held for two minutes against abnormal tissue. Cryotherapy involves freezing temperatures of -22 to -30 0 C, which results in crystallisation and evaporation of intracellular fluid and ultimately destruction of cells at -850C.Being the recommended ablative method of choice by WHO for symptomatic cervical ectropion, it has the advantage of not requiring electricity, being simple to use and also being effective.[8] But it’s limited applicability to large lesions and frequent side effects limit its potential to be the ideal option for patients. Also, the costs and difficulties in ensuring uninterrupted supply of CO2 or N2O refrigerant gas, the long treatment duration and the difficulties with equipment failure have led to problems for treatment providers as well. 
Intervention  Thermoablation  Thermoablation is an alternative method to cryotherapy. Similar effectiveness between thermoablation and cryotherapy has been found in published studies [9] . The primary advantage of this technique is the ease of application, short treatment duration and possibility of multiple applications for large lesions. It uses an electric battery to generate temperatures of 100°C–120°C for ablation of cervical lesions. The procedure is quick and achieves a treatment depth of 4–7 mm. The equipment is light, easily portable, and has an incorporated automatic self-sterilization feature. In addition, only few adverse effects have been reported. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women >21 years of age with symptomatic cervical ectropion including persistent discharge ,post coital bleeding and intermenstrual bleeding.
Persistence of atleast 1 symptom for 3 months or recurrence of symptoms twice in 3 months despite obtaining medical treatment.
Normal PAP smear.
Visible cervical ectropion >0.5 cm from the external os.
Willingness of the patient to participate in the study.
Women understanding spoken or written hindi.
 
 
ExclusionCriteria 
Details  Women with diagnosed Carcinoma Cervix or pre-invasive lesion of cervix in the past.
Previous cervical ablation procedures and loop electrosurgical excision procedure (LEEP).
Pregnant women.
Women with active vaginal infection.
Women currently using oral contraceptive pills.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the size of the cervical ectropion 6 & 12 weeks after colposcopic guided thermoablation.  Baseline
6 weeks
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the WHOQOL-BREF questionnaire score.


 		 Baseline
6 weeks
12 weeks 
Change in the severity of symptoms assessed with the VAS analogue scale.

 		 Baseline
6 weeks
12 weeks 

Percentage of women experiencing side effects at 6 weeks & 12 weeks post procedure
 		 Baseline
6 weeks
12 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3 
Date of First Enrollment (India)   02/11/2023 
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="0"
Months="6"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soniharbani@gmail.com].

  6. For how long will this data be available start date provided 28-03-2024 and end date provided 28-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Although most occurrences of cervical ectropion are asymptomatic,it can occasionally cause vaginal discharge,post coital bleeding ,amd intermenstrual bleeding. The most pouplar form of treatment for this condition is cryotherapy, however it has drawbacks such as excessive watery discharge and li,ited application in larger lesions.A relatively recent technique called thermoablation is quick and capable of treating larger lesions . However there is paucity of studies that show it’s effectiveness in treating cervical ectropion. This study is hence being undertaken to study the effect of thermoablation on the size of ectropion, symptomatology and quality of life (QOL) in women with symptomatic cervical ectropion. 
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