JPRN-jRCT2052220073招募中3 期
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
Horii Yoshihiro0 个研究点目标入组 158 人开始时间: 2022年8月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
入选标准
- •1) Patients with initial and primary rectal cancer.
- •2) Patients with cStage 0 to cStage III.
- •3) Patients who are scheduled to undergo laparoscopic rectal resection and temporal colostomy.
- •4) 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:
- •1) Patients who are scheduled to undergo open abdominal surgery.
- •2) Patients who had a history of intraperitoneal surgery except for appendicitis, Caesarean section, or laparoscopic cholecystectomy.
- •3) Patients who are scheduled to remove specimens from the site other than the midline incision (except in the case of robotic surgery).
- •4) Patients whose performance Status >=3. 5) Patients with 35 or higher of BMI.
- •During Operation:
- •1) Patients who need to undergo open abdominal surgery during laparoscopic procedure.
- •2) Patients who did not have a temporary colostomy.
- •3) Patients whose specimen was removed from a site other than the midline wound (except in the case of robotic surgery).
- •4) Patients who underwent colostomy at the umbilical site
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