Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients scheduled to undergo robotic-assisted colorectal resection with D3 lymphadenectomy (including high ligation of the inferior mesenteric artery) for sigmoid colon cancer or rectal cancer (or suspected cases). 2) Patients with a clinical tumor depth of cT1 to cT3. 3) Patients with an ECOG Performance Status of 0 to 2. 4) Patients who are willing to participate in this study, have provided written informed consent, and are 20 years of age or older at the time of consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding patients, or those with a possibility of pregnancy 2. Patients in whom lymph node dissection is not performed 3. Patients diagnosed with multiple colorectal cancers 4. Patients with a history of colorectal resection 5. Patients diagnosed preoperatively with bowel obstruction, perforation, or penetration 6. Patients diagnosed preoperatively with PDM 7. Patients scheduled for robot-assisted surgery but converted preoperatively to open or laparoscopic surgery 8. Patients whose consent cannot be obtained due to inability to confirm their own will (e.g., dementia, impaired consciousness) 9. Patients with poorly controlled diabetes mellitus 10. Patients with unstable angina (angina pectoris that developed within the past 3 weeks or has worsened recently) or a history of myocardial infarction within the past 6 months 11. Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy 12. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs 13. Patients with a history of chemotherapy or radiotherapy 14. Any other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from the initiation of medial or lateral peritoneal incision to the completion of mesocolic mobilization, including central vascular ligation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Surgical outcomes Operative time (minutes) Dissection time (minutes) Blood loss (mL) Intraoperative complications (yes/no) Conversion rate to laparoscopic or open surgery Quality of dissection (video assessment) 2. Postoperative course Postoperative hospital stay (days) Postoperative complications within 30 days (Clavien Dindo classification) Readmission within 30 days (yes/no) Reoperation within 30 days (yes/no) 3.Long term outcomes Recurrence (yes/no) Site of recurrence Time to recurrence (months from surgery) Survival status (overall survival, recurrence free survival) 4.Learning curve evaluation Changes in operative time and dissection time according to case sequence for each surgeon Analysis using CUSUM method 5.Surgeon stress assessment Evaluated immediately after surgery using the SURG TLX questionnaire | — |
Countries
Japan
Contacts
Kariya Toyota General Hospital Department of Gastrointestinal Surgery