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临床试验/NCT02455752
NCT02455752已完成不适用

Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

Mansoura University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Feasibility of the procedure

研究概览

简要总结

The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

详细描述

This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach.

Data will be registered prospectively and the perioperative outcomes will be assessed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery

排除标准

  • contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.

结局指标

主要结局

Feasibility of the procedure

时间窗: 1 day

Feasibility of the TME by the retroperitoneal approach.

次要结局

  • Intraoperative morbidity(1 day)
  • Postoperative morbidity(Till patient discharge)
  • Pathologic report outcome(7 days)

研究者

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

Osama Mohammad Ali ElDamshety

Assisstant Lecturer of surgical oncology

Mansoura University

研究点 (2)

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