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临床试验/NCT02488577
NCT02488577Unknown不适用

Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study

Osama Mohammad Ali ElDamshety0 个研究点目标入组 50 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Overall percent of postoperative complications.

研究概览

简要总结

Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • T2 N0 low rectal cancer

排除标准

  • patients unfit for laparoscopic resection
  • Unwilling to share in the study

研究组 & 干预措施

TAMIS TME

Active Comparator

T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.

干预措施: Transanal minimally invasive total mesorectal excision (Procedure)

TAMIS-Local

Active Comparator

T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.

干预措施: transanal minimally invasive locoregional resection (Procedure)

结局指标

主要结局

Overall percent of postoperative complications.

时间窗: 30 days

the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.

次要结局

  • Recurrence.(2 years)
  • Hospital stay(30 days)

研究者

发起方
Osama Mohammad Ali ElDamshety
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Osama Mohammad Ali ElDamshety

Assistant lecturer of surgical oncology.

Mansoura University

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