Rectum tumor Rectum tumor Recum cancer
Conditions
Interventions
This is a prospective single arm open label pilot study. The study will evaluate the safety and effectiveness of intraoperative anatomical structure visualization using EUREKA during robot assisted co
Real-time intraoperative image-recognition
Sponsors
Hanaoka Marie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older at the time of registration. Patients with an ECOG PS of 0 or 1. Patients whose primary tumor is located in the rectum based on a comprehensive preoperative diagnosis using endoscopy and imaging examinations, including barium enema examination or upper abdominal and pelvic CT. Patients histopathologically diagnosed with colorectal cancer, including adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, or adenosquamous carcinoma, based on endoscopic biopsy of the primary colorectal lesion. Patients with a preoperative diagnosis of cT1 to cT4 according to the 8th edition of the TNM classification. Patients with direct invasion to other organs, classified as SI or AI according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma, will be excluded. There are no restrictions on cN or cM stage. Patients scheduled to undergo robot assisted low anterior resection, intersphincteric resection, or abdominoperineal resection. Patients scheduled to undergo lateral lymph node dissection will be excluded. Patients who provide written informed consent to participate in this study. ECOG PS, Eastern Cooperative Oncology Group Performance Status, is a scale used to assess the general condition of patients with cancer, ranging from 0, fully active, to 5, death. In this study, patients with PS 0 or 1, who are almost fully independent in daily life, will be included.
Exclusion criteria
Exclusion criteria: Patients with an infection requiring systemic treatment. Patients with a fever of 38.0 C or higher at the time of registration. Patients with uncontrolled diabetes mellitus. Patients with uncontrolled hypertension. Patients with unstable angina, defined as angina that developed or worsened within the previous 3 weeks, or a history of myocardial infarction within the previous 6 months. Patients with uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. Patients with a psychiatric disorder or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult. Patients who require conversion to open surgery during the operation. Patients in whom the planned surgical procedure is not performed. Patients with a history of pelvic surgery, such as rectal resection, radical prostatectomy, or total hysterectomy, or a history of radiation therapy to pelvic organs. Patients with severe preoperative urinary dysfunction. Patients receiving continuous systemic administration of corticosteroids or other immunosuppressive drugs, either orally or intravenously. Women who are pregnant, possibly pregnant, within 28 days after delivery, or breastfeeding. Patients who are judged by the principal investigator or subinvestigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early intraoperative and postoperative outcomes Operative time, blood loss, time to initiation of oral intake, and postoperative length of hospital stay will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative urinary dysfunction The frequency of postoperative urinary dysfunction will be assessed in all eligible patients. It will be compared with historical controls using Fisher exact test. Educational effect for surgeons The educational effect of EUREKA for surgeons will be assessed by questionnaire during real-time use in surgery. Accuracy of EUREKA The accuracy of EUREKA will be assessed by surgeons using a questionnaire during real-time use in surgery. Reduction of burden on supervising surgeons The effect of EUREKA on reducing the burden on supervising surgeons will be assessed by questionnaire during intraoperative instruction. Educational effect for medical students Medical students who observe the surgery during clinical training at Institute of Science Tokyo Hospital will complete a questionnaire. The questionnaire will assess whether EUREKA improves their understanding of the surgical procedure and learning effect. | — |
Contacts
Public ContactMarie Hanaoka
Institute of Science Tokyo
Outcome results
None listed