Cervical Neoplasia
Conditions
Keywords
cervical neoplasia, treatment, thermal ablation, longitudinal study, LMIC
Brief summary
Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.
Detailed description
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.
Interventions
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.
Sponsors
Kamenge University Hospital, Burundi University, Burundi
International Agency for Research on Cancer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate based on VIA and colposcopy assessment | 1 year | Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment. |
| Acceptability of thermal ablation | 6 weeks | Measured by existence of minor/moderate adverse events during the follow-up. |
| Safety of thermal ablation | 1 year | Measured by existence of severe adverse events during the follow-up period. |
Countries
Burundi
Outcome results
None listed