Tokyo, Aug. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058932) titled 'Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial' on Aug. 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Department of Gastrointestinal Surgery, Kariya Toyota General Hospital
Condition:
Condition - Colorectal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate, in a multicenter randomized phase III trial, whether the lateral approach shortens mesocolic dissection time compared with the medial approach in robotic-assisted surgery for left-sided colorectal cancer.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Patients undergoing robotic-assisted left-sided colorectal cancer surgery using the lateral approach, in which mesocolic dissection is initiated by incising the lateral peritoneum.
Interventions/Control_2 - Patients undergoing robotic-assisted left-sided colorectal cancer surgery using the medial approach, in which mesocolic dissection is initiated near the central vessels.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key 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.
Key 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
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 24 Day
Date of IRB - 2025 Year 08 Month 27 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067155
Disclaimer: Curated by HT Syndication.
