Recurrence in High-grade Lesions After Conization

Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02540421

Enrollment

103

Registered

2015-09-04

Start date

2001-01-31

Completion date

2007-12-31

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasia, human papillomavirus, conization

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Recurrence rates after conization	12 months	Number of patients who are regarded as recurrence based on the following criteria: \- relapse occurred when cytology and/or biopsy showed that CIN had returned after 12 months

Countries

Brazil

Outcome results