A multicenter, prospective, single-arm, study on the usefulness of blood flow evaluation of anastomotic site using the SPY-QP software system in rectal cancer minimally invasive surgery.

Watanabe Jun0 个研究点目标入组 400 人开始时间: 2023年7月10日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•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 resectionwith intestinal anastomosis (including ISR, taTME)
•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 within 28 days prior to the surgery.
•8. About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant

•1. Patients who are allergic to iodine orindocyanine green
•2. Planned surgery is rectal resection with combined resection of adjacent organ
•3. Preoperative intestinal obstruction patients
•4. Patients planning simultaneous resection of other organs due to double cancer
•5. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer
•6. Patients with intraperitoneal infection (peritonitis or abdominal abscess)
•7. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.)
•8. Concerning females, pregnancy and patients with fear thereof
•9. Other patients judged inappropriate by the examining physician

发起方

Watanabe Jun