Rectal cancer
Conditions
Interventions
Evaluation of blood flow by VPI, SPY PHI and SPY-QP Fluorescence Assessment Software.
Sponsors
Watanabe Jun
Uemura Mamoru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leakage rate(Grade A+B+C) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anastomotic leakage rate(Grade B+C) Time to fluorescence at the most proximal colon which can be found under open procedure Tmax Relative value of fluorescent intensity at the transection line Rate of the additional transection Length of the additional transection of the proximal colon toward the oral side Rates of complications during surgery Rates of complications within 30 days after surgery Reoperation rate Postoperative hospital stay | — |
Contacts
Public ContactAtsushi Hamabe
The University of Osaka Hospital
Outcome results
None listed