Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Universidade Cidade de Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Other: Follow-up for spontaneous regression of the lesion; Procedure: Excision of the lesion

Study type: Interventional

Funder types: Other

Identifiers

NCT00733109

CIN 2

Details and patient eligibility

About

The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Full description

Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.

The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological CIN2 diagnosis

Exclusion criteria

• Previous CIN treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

excision of the lesion

Active Comparator group

Treatment:

Procedure: Excision of the lesion

espontaneous regression

No Intervention group

Treatment:

Other: Follow-up for spontaneous regression of the lesion