Rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this clinical study: Age 18 years of age or older at the time of registration. Eastern Cooperative Oncology Group performance status of 0 or 1. Patients whose primary tumor site is diagnosed as the rectum based on a comprehensive assessment using preoperative endoscopy and imaging: barium enema and/or abdominopelvic CT. Patients histopathologically diagnosed with colorectal cancer: adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, or adenosquamous carcinoma, by endoscopic biopsy of the primary colorectal lesion. Preoperative diagnosis of cT1-4 (TNM Classification, 8th edition), excluding direct invasion into other organs (SI or AI according to the Japanese Classification of Colorectal Carcinoma, 9th edition). Clinical N and M stages are not restricted. Patients scheduled to undergo robot-assisted low anterior resection, intersphincteric resection, or abdominoperineal resection. Cases requiring lateral pelvic lymph node dissection will be excluded. Written informed consent for participation in this study is obtained from the patient.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: Presence of any of the following severe comorbidities: Active infection requiring systemic therapy. 1.Fever 38.0 degrees Celsius or higher at the time of registration. 2.Uncontrolled diabetes mellitus. 3.Uncontrolled hypertension. 4.Unstable angina (angina newly developed or exacerbated within the past 3 weeks) or history of myocardial infarction within the past 6 months. 5.Uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 6.Psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult. 7.Conversion to open surgery during the operation. History of pelvic surgery (e.g., rectal resection, total prostatectomy, hysterectomy) or history of pelvic radiotherapy. Presence of severe preoperative voiding dysfunction. Ongoing systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive agents. Female patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Any other condition judged by the principal investigator or sub-investigator to render the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of intraoperative and postoperative complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative course, including intraoperative and early postoperative outcomes Incidence of postoperative urinary dysfunction Questionnaire on the educational impact, accuracy, and reduction of supervisory burden associated with the use of EUREKA | — |
Countries
Japan
Contacts
Institute of Science Tokyo Department of Gastrointestinal Surgery