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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Recurrence rates after conization
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •history of surgery for conization
排除标准
- •under 18 years of age,
- •immunosuppressed,
- •Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
- •Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.
结局指标
主要结局
Recurrence rates after conization
时间窗: 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
次要结局
未报告次要终点
研究者
Emerson Oliveira
PhD
Faculdade de Medicina do ABC
