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临床试验/jRCT2052220073
jRCT2052220073招募中不适用

A multicenter, pivotal study to demonstrate non-inferiority of Cyt-006 compared to Seprafilm in patients with primary rectal cancer and temporal colostomy underwent laparoscopic surgery

Cytori Therapeutics K.K.0 个研究点目标入组 158 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
158
主要终点
-
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Prevention Purpose
盲法
Single Blind

入排标准

年龄范围
20age 0month 0week old over 至 No limit（—）

入选标准

  • •Patients with initial and primary rectal cancer.
  • •Patients with cStage 0 to cStage III.
  • •Patients who are scheduled to undergo laparoscopic rectal resection and temporal colostomy.
  • •Patients who are scheduled to undergo the closure of artificial anus at 8 to 48 weeks after initial surgery.

排除标准

  • •Pre-operation:
  • •Patients who are scheduled to undergo open abdominal surgery.
  • •Patients who had a history of intraperitoneal surgery except for appendicitis, Caesarean section, or laparoscopic cholecystectomy.
  • •Patients who are scheduled to remove specimens from the site other than the midline incision (except in the case of robotic surgery).
  • •Patients whose performance Status >=
  • •Patients with 35 or higher of BMI.
  • •During Operation:
  • •Patients who need to undergo open abdominal surgery during laparoscopic procedure.
  • •Patients who did not have a temporary colostomy.
  • •Patients whose specimen was removed from a site other than the midline wound (except in the case of robotic surgery).
  • •Patients who underwent colostomy at the umbilical site

结局指标

主要结局

-

presence/absence of adhesion

次要结局

未报告次要终点

研究者

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