Cancer
Conditions
Interventions
Thermal ablation for 30 seconds without lignocaine use
Thermal ablation for 20 seconds without lignocaine use
Thermal ablation for 30 seconds with lignocaine use
Thermal ablation for 20 seconds with lignocaine use
Controled group
Sponsors
International Agency for Research on Cancer
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Clinically healthy women aged 25-59 years, not pregnant, with an intact uterus and with no history of debilitating physical and mental illness - Screen positive women with colposcopically suspected high-grade lesions (CIN 2/CIN 3) fulfilling the eligibility criteria for ablative treatment. Biopsies will be obtained from the cervical lesion(s) prior to treatment and the results will be reviewed post-treatment. - Women with histopathologically confirmed CIN 2/3 fulfilling the eligibility criteria for ablative treatment. - Women providing informed consent voluntarily The eligibility criteria for ablative treatment are as follows: - The entire squamocolumnar junction is visible and the transformation zone is of type 1 - The lesion does not occupy more than 75% of the cervix and does not extend to the endocervix or vagina - There is no evidence of invasive cervical cancer or glandular abnormality
Exclusion criteria
Exclusion criteria: - Pregnant woman - No histological confirmation of CIN2/CIN3 - Informed consent not provided - Suspicion of cervical cancer - Lesion not eligible for ablative treatment (large lesion, endocervical lesion, squamocolumnar junction not visible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Feasibility, acceptability, safety, clinical utility and effectiveness of thermal ablation in the prevention of cervical lesions - Comparison of the intensity of pain during thermal ablation between women receiving an application of local anaesthesia (lignocaine spray) and women not receiving local anaesthesia - Comparison of the cure rates of lesions treated by thermal ablation at two different durations of treatment: 20 seconds and 30 seconds. | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction level of treatment by thermal ablation. | — |
Countries
Zimbabwe
Contacts
Public ContactBothwell Guzha
Gynaecological Oncologist
Outcome results
None listed