Recurrence in High-grade Lesions After Conization

ABC Foundation (FUABC)

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Study type: Observational

Funder types: Other

Identifiers

NCT02540421

CIN1701

Details and patient eligibility

About

Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).

Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.

Enrollment: 103 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. history of surgery for conization

Exclusion criteria

1. under 18 years of age,
2. immunosuppressed,
3. Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
4. Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

Trial design

103 participants in 2 patient groups

Case

Description:

Recurrent lesions

Control

Description:

Absence of lesions