Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.

Saint Thomas Hospital (HST)

Status: Completed

Conditions: LSIL, Low-Grade Squamous Intraepithelial Lesions

Treatments: Procedure: Ablative treatment; Procedure: Expectant management

Study type: Interventional

Funder types: Other

Identifiers

NCT02331550

MHST2014-01

Details and patient eligibility

About

To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.

Enrollment: 250 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology.
• Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy.

Exclusion criteria

• Serological detection of human immunodeficiency virus (HIV).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Expectant treatment

Experimental group

Description:

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.

Treatment:

Procedure: Expectant management

Ablative treatment

Experimental group

Description:

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.

Treatment:

Procedure: Ablative treatment