Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
REAL2
Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial
1 other identifier
interventional
1,596
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
May 4, 2025
April 1, 2025
6 years
March 25, 2025
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival rate
The 3-year disease-free survival (DFS) rate was defined as the percentage of patients with no death and no locoregional recurrence and no distant metastases within 3 years postoperatively, assessed via imaging (contrast-enhanced CT/MRI, PET-CT) or histopathological confirmation (colonoscopy/biopsy).
3 years after surgery
Secondary Outcomes (6)
30-day postoperative complication rate
30 days after surgery
Urinary function
1 year after surgery
Male sexual function
1 year after surgery
Female sexual function
1 year after surgery
Defecation function
1 year after surgery
- +1 more secondary outcomes
Other Outcomes (25)
Intraoperative complication rate
30 days after surgery
Open conversion rate
30 days after surgery
Operative time
30 days after surgery
- +22 more other outcomes
Study Arms (2)
IMA-LN Preservation
ACTIVE COMPARATORPatients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), but preserving the lymph nodes at the root of the inferior mesenteric artery (IMA).
IMA-LN Dissection
PLACEBO COMPARATORPatients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), and dissecting the lymph nodes at the root of the inferior mesenteric artery (IMA).
Interventions
Patients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), and dissecting the lymph nodes at the root of the inferior mesenteric artery (IMA).
Patients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), but preserving the lymph nodes at the root of the inferior mesenteric artery (IMA).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinical complete response after radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- cT1N0 tumors suitable for local excision
- 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
- Concomitant conditions requiring concurrent colonic resection
- American Society of Anesthesiologists (ASA) grade \>III
- Pregnancy or lactation
- Preoperative short-course radiotherapy
- Inability of the patient/family to comprehend the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianmin Xu, Prof.
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of Colorectal Surgery Department
Study Record Dates
First Submitted
March 25, 2025
First Posted
May 4, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
May 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available from the publication date until 36 months post-publication.
- Access Criteria
- De-identified patient data will be accessible to all investigators in this study and may be used for meta-analysis after audit and validation. Researchers should contact the principal investigator, Professor Jianmin Xu (xujmin@aliyun.com), to request data by providing a research proposal and institutional credentials.
During the recruitment process, investigators will directly contact enrolled patients to avoid privacy breaches. All identity-related data will be stored separately in locked systems and de-identified. All researchers must refrain from disclosing patients' identifiable information. De-identified patient data will be accessible to all investigators in this study and may be used for meta-analysis after audit and validation. Researchers should contact the principal investigator, Professor Jianmin Xu (xujmin@aliyun.com), to request data by providing a research proposal and institutional credentials. Requests will be reviewed and approved by the REAL2 trial's Independent Review Committee. Data will be available from the publication date until 36 months post-publication.