NCT02562729已完成2 期
A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study
Shanghai Gynecologic Oncology Group1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportion of patients with fully pelvic nerve plexus preserved
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.
详细描述
The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) <50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years to <= 70 years.
- •Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
- •Stage IIA1, or IB1 disease.
- •Karnofsky performance status >
- •Patients who comply with follow-up.
- •With written informed consent.
排除标准
- •History of lower urinary tract damage or surgery.
- •With abnormal urodynamic study results.
- •Karnofsky performance status <
- •Patients who have uncontrolled psychological disorders.
- •Unwilling to or unable to comply with protocol.
- •Prior treatment with pelvic radiotherapy
结局指标
主要结局
Proportion of patients with fully pelvic nerve plexus preserved
时间窗: up to 30 days
Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
Proportion of patients removing indwelling catheter
时间窗: up to 30 days
次要结局
- The rate of 36-month local control(up to 36 months)
研究者
研究点 (1)
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