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Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial

Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118702
Enrollment
Unknown
Registered
2026-02-10
Start date
2025-05-09
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mid-low rectal cancer

Interventions

IMA-LN sweeping group:Cleansing of lymph nodes at the start of the IMA
IMA-LN Reserved Group:No clearance of lymph nodes in the root of the inferior mesenteric artery

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age greater than 18 and less than or equal to 80 years old; 2.Colonoscopic biopsy pathology confirms diagnosis of rectal adenocarcinoma; 3.Tumour less than or equal to 10cm from anal verge; 4.No root lymph node metastasis to the inferior mesenteric artery and no lateral lymph node metastasis as determined by ultrasound, enhanced CT and/or PET-CT (diagnosis of metastatic lymph nodes based on CSCO Guidelines 2024 edition); 5.Absence of distant metastases (including pelvic, peritoneal, hepatic, pulmonary, cerebral, skeletal, and distant lymph node metastases) as determined by ultrasound, enhanced CT and/or PET-CT, etc. 6.Pelvic MRI and/or transrectal intraluminal ultrasonography to determine that the tumour is cT1-T3 N0-1, or ycT1-T3 Nx after neoadjuvant therapy (preoperative radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.); 7.No history of other malignant disease (except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 8.Suitable for robotic surgery; 9.informed consent;

Exclusion criteria

Exclusion criteria: 1.Complete clinical remission of the tumour after radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. 2.cT1N0 suitable for local excision; 3.Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc; 4.Multiple primary colorectal malignancies; 5.Familial adenomatous polyposis (FAP), Lynch syndrome, inflammatory bowel disease; 6.Other conditions requiring simultaneous colectomy; 7.American Society of Anaesthesiologists (ASA) classification greater than III; 8.Pregnancy and lactation; 9.Preoperative short course radiotherapy; 10.Inability of the patient or family to understand the conditions and objectives of the study;

Design outcomes

Primary

MeasureTime frame
3-year relapse-free rate;

Secondary

MeasureTime frame
Quality of life;Short-term postoperative rehabilitation outcomes;Pathological findings;Long-term survival outcomes;End of Health Economics;Quality of surgery;

Countries

China

Contacts

Public ContactJianmin Xu

Zhongshan Hospital, Fudan University

xujmin@aliyun.com+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026