NCT05933785已完成不适用
The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer
Shanghai Minimally Invasive Surgery Center2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2018年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- anal preservation rate
研究概览
简要总结
The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) score I to III
- •A biopsy proven histological diagnosis of rectal carcinoma
- •preoperative stage as (y) cT1-3N0-2M0
- •lower margin of the tumor less than 5cm from the anus
- •tumor diameter ≤5cm
排除标准
- •Pregnant or lactating women
- •Synchronous rectal carcinoma
- •History of colorectal cancer or other malignant tumors
- •Clinical evidence of metastasis
- •Emergency procedure
结局指标
主要结局
anal preservation rate
时间窗: 1 year after sugery
No conversion to APR and closure was closed within 1 year after surgery
次要结局
- incidence of Defecation disorders(6 months after surgery)
- incidence of positive distal resection margin(30 days after surgery)
研究者
研究点 (2)
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