Recurrence in High-grade Lesions After Conization

NCT ID: NCT02540421

Last Updated: 2015-09-04

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

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case

Recurrent lesions

No interventions assigned to this group

Control

Absence of lesions

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Responsible Party

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Emerson Oliveira

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EMERSON OLIVEIRA, PhD

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE OF ABC

Locations

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Emerson de Oliveira

Santo André, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CIN1701

Identifier Type: -

Identifier Source: org_study_id

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