跳至主要内容
临床试验/NCT03281070
NCT03281070Unknown不适用

The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Anastomotic leakage

研究概览

简要总结

Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • adenocarcinoma of the rectum by biopsy
  • single lesion
  • anterior resection was performed
  • anastomosis using circular stapler

排除标准

  • history of colorectal cancer surgery
  • emergency surgery because of bowel obstruction, bleeding or perforation
  • colo-anal anastomosis
  • subtotal colectomy
  • total colectomy
  • abdominal perineal resection
  • Hartmann procedure
  • pull out anastomosis

结局指标

主要结局

Anastomotic leakage

时间窗: 14 days after surgery

Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments.

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

Zhongtao Zhang

Department of General Surgery

Beijing Friendship Hospital

研究点 (1)

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