Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Study Overview
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Brief Summary
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Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Detailed Description
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The study population consisted of women with an abnormal VIA test or an abnormal colposcopy examination. A total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. They were followed-up at 6 weeks for any complication and re-assessed by VIA and colposcopy at 12 months for any persistent or recurrent lesion and for any adverse event.

Official Title
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Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Conditions
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Cervical Neoplasia

Intervention / Treatment
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* Device: Treatment of cervical neoplasia by thermal ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women residing in Burundi and referred to the tertiary hospital after a positive VIA test Exclusion Criteria: Lesion occupying the 4 quadrants of the cervix Not visible squamous columnar junction (not Type 1 TZ) Vaginal or endocervical lesion Lesion subjective of cervical cancer
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Treatment of cervical neoplasia by thermal ablation | Device: Treatment of cervical neoplasia by thermal ablation<br>* Women screened for cervical cancer by visual inspection with diluted acetic acid (VIA) presenting lesions eligible for ablative treatment were treated by thermal ablation. The treatment consisted in applying the probe on the lesion for 45 seconds at 100 degrees Celsius, with one to up to five applications depending on the lesion size. Following treatment, women were inquired about the pain level during the procedure, their satisfaction level of the procedure and whether they would recommend this treatment to their relatives. Women had a follow-up visit at 6 weeks to assess any complication of the procedure. Women were rescreened at 12 months, to evaluate the cure rate and any long-term adverse events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate based on VIA and colposcopy assessment | Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment. | 1 year | 
| Acceptability of thermal ablation | Measured by existence of minor/moderate adverse events during the follow-up. | 6 weeks | 
| Acceptability of thermal ablation | Measured by the satisfaction level using a nine-level Likert scale (from 1. Very unsatisfied to 9. very satisfied). | At day 1 | 
| Safety of thermal ablation | Measured by existence of severe adverse events during the follow-up period. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical neoplasia, treatment, thermal ablation, longitudinal study, LMIC