Randomised Intervention Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- The primary end point is the cure rate at the end of one year
Study Overview
Brief Summary
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects and complications.
Detailed Description
Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to ectocervix without extension to endocervix or vagina will be randomized to single- or double-freeze cryotherapy, as per the inclusion criteria will be invited to participate in the study.
They will be explained about the study. Informed consent will be obtained from each recruited woman. The cases selected with lesions that can be adequately covered with largest cryo probe (2.5 cm diameter) will be randomized between the following arms.
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
The patients will be advised about excessive discharge per vagina for 4 weeks and mild abdominal cramps.
They will be advised to abstain from sexual intercourse for 6 weeks. They would be followed up after one month for clinical evaluation and at 12th month to determine the cure rates by Pap test, HPV Test and colposcopy with or without biopsy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary end point is the cure rate at the end of one year
Time Frame: 1 year
The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.
Secondary Outcomes
- The secondary end points are the rates and the types of side effects and complications(1 year)
Investigators
Gauravi Ashish Mishra
Associate professor Department of Preventive Oncology
Tata Memorial Hospital