JPRN-jRCTs031180039已完成未知
Randomized phase III trial evaluating the efficacy of near-infrared fluorescence imaging on Anastomotic Leakage in Laparoscopic surgery of rectal cancer. - EssentiAL study
Takemasa Ichiro0 个研究点目标入组 850 人开始时间: 2018年11月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 850
研究概览
简要总结
Blood flow evaluation by ICG fluorescence method significantly reduced the incidence of anastomotic leak for rectal cancer surgery with AV of 12 cm or less. It also significantly reduced the reoperation rate. Blood flow evaluation by ICG fluorescence method is recommended for rectal cancer surgery with AV of 12 cm or less.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients who are histologically proven to be rectal cancer
- •2.The lower edge of the tumor is within 12 cm from the anal verge
- •3.Patients diagnosed with Stage 0-3 in preoperative diagnostic imaging
- •4.Patients who are scheduled for rectal resection with intestinal anastomosis (including ISR)
- •5.Patients with General State Performance Status (ECOG) 0 to 2
- •6.Patients whose age at registration is 20 years or older
- •7.Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination
- •8.About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant
排除标准
- •1. Patients who are allergic to iodine or indocyanine green
- •2. Preoperative intestinal obstruction patients
- •3. Patients planning simultaneous resection of other organs due to double cancer
- •4. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer
- •5. Patients with intraperitoneal infection (peritonitis or abdominal abscess)
- •6. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.)
- •7. Concerning females, pregnancy and patients with fear thereof
- •8. Other patients judged inappropriate by the examining physician
研究者
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