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Clinical Trials/CTRI/2022/11/047036
CTRI/2022/11/047036CompletedNot Applicable

Cryotherapy As A Mode Of Treatment In Cervical Erosion: An Observational Study

Rohilkhand Medical College and Hospital1 site in 1 country74 target enrollmentStarted: July 11, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
To assess the symptomatic improvement among patients after cryotherapy

Study Overview

Brief Summary

This is an Observational study to assess Cryotherapy as a mode of treatment of cervical erosion. This study will be conducted at Gynecology OPD RMCH, Bareilly, UP over a period of one year. The study will recruit 76 patients of cervical erosion according to the inclusion and exclusion criteria , in whom the effect of cryotherapy  will be studied. The primary outcome will be To assess the symptomaticimprovement among patients after cryotherapy and the secondary outcome ) (1)To document any complications of cryotherapy  (3) To analyze the features associated withsuccess of cryotherapy

Since,there are few  studies  in the state of Uttar Pradesh , with regardsto cryotherapy,  we decided to determineourselves, whether cryotherapy can be safely and effectively used for resolvingsymptoms of cervical erosion in a tertiary care setting.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Women with age between 20 to 40 years 2.Women with Intact uterus 3.Women suffering from any/ more/all of the following Symptoms- Abundant vaginal discharge , pelvic pain, Post coital bleeding, dyspareunia.

Exclusion Criteria

  • 1.Pap smear with premalignant and malignant changes 2.Active genital tract infections 3.Women who are virgin or pregnant or lactating or have attained menopause 4.Women with medical history of OR suffering from hypertension/ diabetes mellitus/ bleeding disorder/any other immunocompromising disease 5.Women taking Oral contraceptive pills 6.Females with history of cervical Neoplasia or premalignant cervical lesion (CIN-1 & CIN-2).

Outcomes

Primary Outcomes

To assess the symptomatic improvement among patients after cryotherapy

Time Frame: 1)Baseline:07/11/22 to 07/11/23 | 2) 1 month (4 weeks) | 3) 3 months(12 weeks)

Secondary Outcomes

  • (1) To document any complications of cryotherapy .((2) To analyze the features associated with success of cryotherapy)

Investigators

Sponsor
Rohilkhand Medical College and Hospital
Sponsor Class
Private medical college

Study Sites (1)

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