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临床试验/NCT02540421
NCT02540421已完成不适用

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

Faculdade de Medicina do ABC1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2001年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emerson Oliveira

PhD

Faculdade de Medicina do ABC

研究点 (1)

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