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临床试验/NCT04969107
NCT04969107招募中不适用

Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study

Cantonal Hospital of St. Gallen2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
disease-specific survival

研究概览

简要总结

This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.

详细描述

Rectal cancer accounts for 3.8% of all new cancer diagnosis and for 3.4% of all cancer-related deaths in the world in 2020. Regarding treatment of rectal cancer, it is essential to perform surgery along the anatomical and embryological planes. This technique called total mesorectal excision (TME) reduces the local recurrence rate and improves the survival. Since the early 2000, TME has changed from open to laparoscopic approach due to better results in short-term outcome. Nevertheless, oncological benefits are modest. In 2009 the first ever transanal TME (taTME) war performed. This novel technique combines abdominal with transanal dissection. Because the distal part of the rectum is approached from below, a better visualization of the mesorectal plane resulting in higher rate of free CRM and of complete TME specimen grade (Quirke Score) can be accomplished. However, taTME remains a hot topic in the current scientific literature. In Norway and the Netherlands a higher rate of anastomotic leakage as well as a higher rate of local recurrence (9.5%) with multifocal growth pattern were described.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients receiving elective total mesorectal excision

排除标准

  • diagnosis other than rectal cancer
  • partial mesorectal excision
  • discontinuity resection (no anastomosis)
  • incomplete Staging
  • metastatic cancer
  • lack of follow-up
  • decline of a retrospective data Analysis
  • age under 18 years

结局指标

主要结局

disease-specific survival

时间窗: 60 months

time from surgery to end of follow-up or death due to or recurrence of rectal cancer

Overall survival

时间窗: 60 months

time from surgery to end of follow-up or death

cancer-specific survival

时间窗: 60 months

time from surgery to end of follow-up or death due to rectal cancer

次要结局

  • positive resection margin(30 days)
  • relapse-free survival(60 months)
  • number of lymph nodes(30 days)
  • postoperative 90-day mortality(90 days)
  • recurrence-free survival(60 months)
  • postoperative morbidity(30 days)
  • Quirke Score(30 days)
  • circular resection margin (CRM)(30 days)

研究者

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

Lukas Marti

Dr. med. Lukas Marti, Leitender Arzt Chirurgie

Cantonal Hospital of St. Gallen

研究点 (2)

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