colorectal cancer
Conditions
Interventions
obot-assisted colorectal cancer surgery with lymph node dissection
Sponsors
Hirosaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Rectum adenocarcinoma 2) Without liver, peritoneum and distant metastases 3)Age of 20-80 years 4) without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 5)Aadequate function of important organs 1. WBC: >=3, 000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <100IU/L 6. T Bil: <=2.0mg/dL 7. Serum creatinine: <=1.2mg.DL 6) ECG: without clinically problematic abnormalities within 28 days before registration 7) Eastern Cooperative Oncology Group performance status (PS) 0-1 8) With ability of oral intake 9) Written informed concent
Exclusion criteria
Exclusion criteria: 1) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 2) with active double cancer 3) had active infection disease (over 38.0 degree) 4) with psychosis or psychological symptom 5) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3 or higher surgical complications (Clavien-Dindo Classification) | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade 2 or higher surgical complications (Clavien-Dindo Classification), medical care cost, obot-assisted colorectal cancer surgery completion rate, With or without conversion from obot-assisted surgery to open surgery, adverse event during surgery, performance of surgery, early postoperative course, surgery-related death, relapse free survival | — |
Countries
Japan
Contacts
Public ContactHajime Morohashi
Hirosaki University Hospital Hirosaki University Hospital
Outcome results
None listed