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.
The goal of this clinical trial is to compare the outcomes of preserving versus dissecting inferior mesenteric artery root lymph nodes (IMA-LN) during robotic radical resection for mid/low rectal cancer. It aims to evaluate both short-term safety and long-term efficacy. The main questions it seeks to answer are: 1. Does preserving IMA-LN achieve non-inferior 3-year disease-free survival (DFS) compared to IMA-LN dissection? 2. Does preserving IMA-LN reduce postoperative complications (e.g., anastomotic leakage, urinary/defecation dysfunction) and improve quality of life? Researchers will compare two surgical strategies: 1. IMA-LN preservation group: No dissection of IMA root lymph nodes, with ligation of the inferior mesenteric artery (IMA) distal to the left colic artery. 2. IMA-LN dissection group: Complete dissection of IMA root lymph nodes, with high or low ligation of the IMA. Both groups will undergo robotic surgery following total mesorectal excision (TME) principles. Participants will: 1. Be randomly assigned to either the preservation or dissection group. Receive standardized preoperative evaluations (imaging, biopsies) and postoperative follow-up for 3 years. 2. Undergo regular clinical assessments, including tumor marker tests, imaging (CT/MRI), colonoscopy, and quality-of-life questionnaires (evaluating urinary/sexual/defecation function). 3. Have surgical outcomes (e.g., complications, lymph node counts) and survival data recorded. The trial aims to provide high-level evidence for optimizing surgical strategies in mid/low rectal cancer treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,596
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).
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
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).
Time frame: 3 years after surgery
30-day postoperative complication rate
The rate of patients with any of postoperative complications (Clavien-Dindo grade II or higher grade) within 30 days after surgery
Time frame: 30 days after surgery
Urinary function
Urinary function will be assessed using the International Prostate Symptom Score (IPSS) scale before surgery, at 3 months, 6 months and 1 year after surgery. For IPSS, the range of the score is 0 to 35, with higher scores indicating worse function.
Time frame: 1 year after surgery
Male sexual function
Male sexual function will be assessed using the International Index of Erectile Function-5 (IIEF-5) scale before surgery, at 3 months, 6 months and 1 year after surgery. For IIEF-5, the range of the score is 1 to 25, with lower scores indicating worse function.
Time frame: 1 year after surgery
Female sexual function
Female sexual function will be assessed using the Female Sexual Function Index (FSFI) scale before surgery, at 3 months, 6 months and 1 year after surgery. For FSFI, the range of the score is 2 to 36, with lower scores indicating worse function.
Time frame: 1 year after surgery
Defecation function
Defecation function will be assessed using the Wexner Continence Grading Scale before surgery, at 3 months, 6 months and 1 year after surgery. For the Wexner scale, the range of the score is 0 to 20, with higher scores indicating worse function.
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Time frame: 1 year after surgery
3-year locoregional recurrence rate
The 3-year locoregional recurrence (LRR) rate was defined as the percentage of patients with any locoregional recurrence within 3 years postoperatively, assessed via imaging (contrast-enhanced CT/MRI, PET-CT) or histopathological confirmation (colonoscopy/biopsy).
Time frame: 3 years after surgery