Colon Cancer (Stage II/III) Colon cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet the following criteria: Pathologically diagnosed with colorectal cancer via endoscopic biopsy. Primary tumor located in the cecum, ascending colon, transverse colon, or descending colon, with planned laparoscopic curative surgery. Preoperative imaging indicates Stage II or III cancer. Age between 20 and 80 years at the time of consent. ECOG performance status of 0 to 2. No bowel obstruction expected to hinder adequate bowel preparation with laxatives. Elective surgery. Double Stapling Technique is not planned. Stoma construction is not planned. No history of bowel resection (with specific gastrectomy types and appendectomy excluded from this definition). No prior chemotherapy or radiation therapy. Written informed consent obtained for study participation.
Exclusion criteria
Exclusion criteria: The patient has the following serious comorbidities: Has an infection requiring systemic treatment. Has a fever of 38.0 or higher at the time of enrollment. Is receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. Has uncontrolled diabetes. Has uncontrolled hypertension. Has unstable angina (new onset within the last 3 weeks or worsening attacks) or a history of myocardial infarction within the last 6 months. Has uncontrolled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. The patient has a mental illness or psychiatric symptoms that interfere with daily life and is judged to have difficulty participating in the study. The patient is pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. The patient is deemed unsuitable for participation in the study by the principal investigator or a sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of Peritoneal Recurrence 2.Overall Survival 3.Intraoperative and Early Postoperative Outcomes: Duration of Surgery Amount of Blood Loss Days until Flatus or Bowel Movement Date of Diet Resumption Use of Analgesics Length of Hospital Stay Post-Surgery 4. Incidence of Surgical Complications Rate of Intraoperative Complications (from the start of surgery to the end of surgery (closure) Rate of Early Postoperative Complications (from the end of surgery (closure) to within 30 days post-surgery) Rate of Late Postoperative Complications (from 31 days post-surgery to within 5 years post-surgery) 5. Rehospitalization Rate within 90 Days Post-Surgery | — |
Contacts
Institute of Science Tokyo