Clinically Stage I to III Resectable Colorectal Cancer Colorectal neoplasms
Conditions
Interventions
Robotic-assisted colorectal resection using hinotori Surgical Robot System
Robotic Surgical Procedures
Sponsors
Kanemitsu Yukihide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 The primary lesion has been histologically diagnosed as adenocarcinoma, including papillary adenocarcinoma, well-differentiated tubular adenocarcinoma, moderately differentiated tubular adenocarcinoma, poorly differentiated adenocarcinoma of type one, poorly differentiated adenocarcinoma of type two, signet-ring cell carcinoma, or mucinous adenocarcinoma. Additionally, the lesion may be diagnosed as a neuroendocrine tumor or neuroendocrine carcinoma based on an endoscopic biopsy. 2 The main tumor location has been comprehensively determined using endoscopic examination and preoperative imaging studies, including contrast enema or abdominal and pelvic computed tomography. The tumor is identified as one of the following: appendix, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid, upper rectum, lower rectum, or anal canal. 3 The tumor is deemed resectable with curative intent, corresponding to clinical stage one to three, with the potential for achieving curative resection. This determination is based on a comprehensive evaluation using preoperative imaging, including chest, abdominal, and pelvic computed tomography. 4 No multiple lesions are detected based on a comprehensive evaluation using endoscopic and preoperative imaging studies, including contrast enema or abdominal and pelvic computed tomography. However, lesions that have been considered curatively treated by endoscopic resection are not classified as multiple lesions. 5 The patient does not present with bowel obstruction requiring preoperative decompression. 6 The patient is aged between twenty and eighty years. 7 The Eastern Cooperative Oncology Group Performance Status is zero or one. 8 The body mass index is less than thirty. 9 The patient has no history of specific surgeries, including gastrointestinal resection, upper abdominal surgery except for laparoscopic cholecystectomy, pelvic lymphadenectomy, or surgery for generalized peritonitis. This criterion applies even if the surgery was performed for other malignancies. However, a history of appendectomy does not disqualify the patient. 10 The following laboratory criteria are met. All tests must be conducted within twenty-eight days before enrollment, with results from the same weekday four weeks prior to the enrollment date being acceptable. i. White blood cell count is at least three thousand per cubic millimeter. ii. Platelet count is at least one hundred thousand per cubic millimeter. iii. Aspartate aminotransferase is one hundred international units per liter or lower, and alanine aminotransferase is one hundred international units per liter or lower. iv. Total bilirubin is two point zero grams per deciliter or lower. v. Serum creatinine is one point five milligrams per deciliter or lower. 11 Written informed consent for study participation has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1 The patient has active multiple primary cancers, including synchronous multiple primary cancers and metachronous multiple primary cancers with a disease-free interval of five years or less. However, lesions that are considered cured by local treatment are not included as active multiple primary cancers. 2 The patient is a woman who is pregnant or has the potential for pregnancy, or is currently breastfeeding. 3 The patient has a psychiatric disorder or psychiatric symptoms that make participation in the study difficult. 4 The patient is receiving continuous systemic administration of steroid agents, either orally or intravenously. 5 The patient has a history of myocardial infarction within six months or has unstable angina. 6 The patient has uncontrolled hypertension. 7 The patient has uncontrolled diabetes mellitus. 8 The patient has a respiratory disease requiring continuous oxygen therapy. 9 The patient is deemed ineligible for the study for any other reason at the discretion of the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of severe perioperative complications [CTCAE v5.0-JCOG / Clavien-Dindo classification ver 2.0, Grade 3 or higher]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The completion rate of robot-assisted colorectal resection | — |
Contacts
Public ContactShota Ariga
National Cancer Center Hospital
Outcome results
None listed