Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer.
Not Applicable
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000030240
- Lead Sponsor
- Sapporo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 850
Inclusion Criteria
Not provided
Exclusion Criteria
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. Pregnancy and patients with fear thereof 8. Other patients judged inappropriate by the examining physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anastomotic leakage rate
- Secondary Outcome Measures
Name Time Method Anastomotic leakage rate(Grade B+C) Fluorescence time at the oral side anastomotic site Rate of the additional transection of the proximal colon toward the oral side Length of the additional transection of the proximal colon toward the oral side Rates of complications within 30 days after surgery Rates of complications during surgery Reoperation rate Postoperative hospital stay