NCT06956976Not yet recruiting
Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this study, patients with middle or low rectal cancer will receive robotic radical resection, and will be randomly assigned to receive inferior mesenteric artery lymph nodes dissection or preservation. The 3-year disease-free survival rates of these two surgical approaches will be compared.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1596 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2031
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06956976
What you commit to
- Study type: Interventional
- Planned participants: 1596
- From 1 Jun 2025 to the primary completion date, 1 Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinical complete response after radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- Concomitant conditions requiring concurrent colonic resection
- Preoperative short-course radiotherapy
Other illness
- Emergency surgery required due to acute bowel obstruction, hemorrhage, or perforation
- Multiple primary colorectal malignancies
- Familial adenomatous polyposis (FAP), Lynch syndrome, or inflammatory bowel disease
Other
- cT1N0 tumors suitable for local excision
- American Society of Anesthesiologists (ASA) grade \>III
- Pregnancy or lactation
- Inability of the patient/family to comprehend the study protocol
Who the study is looking for
- Age \>18 years and ≤80 years
- Pathologically confirmed rectal adenocarcinoma by colonoscopic biopsy
- Tumor located ≤10 cm from the anal verge
- No metastasis at the root of the inferior mesenteric artery (IMA) and no lateral lymph node metastasis confirmed by pelvic ultrasound, contrast-enhanced CT, and/or PET-CT (diagnostic criteria per the 2024 Chinese Society of Clinical Oncology \[CSCO\] Guidelines)
- No distant metastasis (including pelvic, peritoneal, hepatic, pulmonary, cerebral, skeletal, or distant lymph node metastasis) confirmed by imaging
- Pelvic MRI and/or transrectal ultrasound confirming cT1-T3 N0-1 stage, or ycT1-T3 Nx after neoadjuvant therapy (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
- No history of other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ)
- Suitable for robotic surgery
- Signed informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.