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临床试验/NCT05108753
NCT05108753已完成不适用

Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China: Retrospective Study of the First Twenty-five Cases in Seven High-volume Centers

Shanghai Minimally Invasive Surgery Center2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2017年2月1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
175
试验地点
2
主要终点
incidence of anastomotic leakage

研究概览

简要总结

Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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
  • Undergoing transanal total mesorectal excision

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

incidence of anastomotic leakage

时间窗: thirty days after surgery

according to the International Rectal Cancer Study Group

次要结局

  • incidence of positivecircumferential resection margin(30 days after surgery)
  • incidence of Defecation disorders(6 months after surgery)
  • incidence of positive distal resection margin(30 days after surgery)

研究者

发起方
Shanghai Minimally Invasive Surgery Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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