Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2020-08-17

Brief Summary

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Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

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Detailed Description

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The study population consisted of women with a positive Visual Inspection with Acetic Acid (VIA) screening test referred for ablative treatment. A total of 119 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, the patients were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. The women were followed-up at 6 weeks for any complication and re-assessed by colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse event.

Conditions

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Cervical Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm study where women presenting with cervical lesions eligible to ablation were treated and followed-up for cure and adverse events.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thermal ablation Arm

Treatment of cervical neoplasia by thermal ablation

Group Type EXPERIMENTAL

Treatment of cervical neoplasia by thermal ablation

Intervention Type PROCEDURE

Women screened for cervical cancer by 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.

Interventions

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Treatment of cervical neoplasia by thermal ablation

Women screened for cervical cancer by 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women having been screened positive at VIA at the primary health center and referred to the diagnosis centre of Fez and Taza for ablative treatment by thermal ablation

Exclusion Criteria

* Lesion occupying the 4 quadrants of the cervix
* Not visible squamous columnar junction (not Type 1 TZ (transformation zone))
* Vaginal or endocervical lesion
* Lesion subjective of cervical cancer

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No