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COMPARISON OF TWO TREATMENT MODALITIES OF EARLY CERVICAL CANCER (CIN 2&3)LEEP V/S THERMAL ABLATION

THERMAL ABLATION VERSUS LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP)IN TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA CIN 2&3 :AN EXPLORATORY TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032424
Enrollment
60
Registered
2021-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D069- Carcinoma in situ of cervix, unspecified Health Condition 2: 1- Obstetrics

Interventions

Intervention1: TIME BOUND EXPLORATORY TRIAL: Patients will be recruited from Gynecology OPD AIIMS Rishikesh and outreach camps. All women aged 25-55 years will undergo complete history and examination

Sponsors

AII INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with age group 25-55 years 2. Women who have histologically confirmed CIN 2 & 3 lesions 3. Women who have been screened positive (positive with high risk HPV or visual inspection with acetic acid / VIA) in a screen-and-treat strategy. 4. Women with abnormal cytology (High-grade Squamous Intra-epithelial Lesion / HSIL) 5. Transformation zone (TZ) is fully visible, whole lesion is visible and it does not extend into the endocervix, or the lesion is type 1 TZ; or the lesion is type 2 TZ where the probe tip will achieve complete ablation of the SCJ epithelium, i.e., where it can reach the upper limit of the TZ.

Exclusion criteria

Exclusion criteria: • Women with obvious growth on cervix. • Women with high index of suspicion of invasive cancer cervix . • Women with lesion occupying more than two quadrants of cervix or with vaginal and/or endocervical extension. • Lesion is type 3 TZ (TZ is not fully visible because it is endocervical); or lesion is type 2 TZ where the SCJ is out of reach of the probe tip. • Pregnant women • Women with severe debilitating disease • Women with history of pelvic irradiation

Design outcomes

Primary

MeasureTime frame
To evaluate acceptability effectiveness and side effects in women of CIN 2 3 lesions treated with Thermal coagulation and LEEP. 2. Comparing the results in the two treated groups, one by loop electrosurgical excision procedure (LEEP) and one by thermal ablation, in terms of acceptability, efficacy, complications, disease recurrence persistence and on follow up of 6 months. Timepoint: 1,3,6 months—

Secondary

MeasureTime frame
To examine and compare the effect of Thermal ablation and LEEP on overall sexual satisfaction and other specific aspects of sexual function in women in CIN 2 & 3.Timepoint: 6months—

Countries

India

Contacts

Public ContactDR MAHIMA MAHAMOOD M M

ALL INDIA INSTITUTE OF MEDICAL SCIENCE ,RISHIKESH

anupama.bahadur@gmail.com9810326959

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026