Primary rectal cancer
Conditions
Interventions
in surgery,1st postoperative day, 2nd postoperative day, 3rd postoperative day, 4th postoperative day, 5th post operative day, 6th postoperative day, 7th postoperative day and 28th postoperative day o
Sponsors
Ito Masaaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Primary rectal cancer located within 12cm from the anal verge(with or without preoperativetreatment) 2)Histologically proven rectal adenocarcinoma orrectal neuroendocrine tumor 3)Planning elective surgery with excision and anastomosis 4)Age>=20 5)According to the clinical test results within 30 days before registration, the following organ functions are satisfied. WBC>3,000mm^3 Hb>8.0g/dL PLT>100,000mm^3 T-bil<2.0mg/dL AST(GOT)<100U/L ALT(GPT)<100U/L Cr<1.5mg/dL 6)Performance Status ECOG:0 or 1 7)The consent in writing has obtained *1 Regardless of open surgery/laparoscopic surgery *2 Regardless of the reconstructive method *3 Regardless of clinical stage *4 Regardless of the degree of surgical cure *5 With or without comorbidities *6 Cases enrolled in other clinical trials are also acceptable
Exclusion criteria
Exclusion criteria: 1) Emergency surgery is needed 2) Judged inappropriate for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| StO2 in the perfused area at the boundary betwee n the perfused area and the ischemic area determi ned by intraoperative blood flow evaluation by IC G fluorescence | — |
Secondary
| Measure | Time frame |
|---|---|
| Slope of StO2 curve at the boundary between perf used area and ischemic area judged by intraopera tive blood flow evaluation by ICG fluorescence method Distance between perfused area and ischemic are a judged by intraoperative blood flow evaluation b y OXEI and ICG fluorescence method StO2 in intraoperative and postoperative evaluatio n using OXEI Hemoglobin index in intraoperative and postopera tive evaluation using OXEI Test equipment failure rate Rate of adverse events of Grade 3 or higher and G rade 4 or higher caused by test equipment Incidence of suture failure | — |
Contacts
Public ContactMasaaki Ito
National Cancer Center Hospital East
Outcome results
None listed