Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
- Conditions
- Rectal Cancer
- Registration Number
- NCT06956976
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1596
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 3-year disease-free survival rate 3 years after surgery 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).
- Secondary Outcome Measures
Name Time Method 30-day postoperative complication rate 30 days after surgery The rate of patients with any of postoperative complications (Clavien-Dindo grade II or higher grade) within 30 days after surgery
Urinary function 1 year after surgery 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.
Male sexual function 1 year after surgery 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.
Female sexual function 1 year after surgery 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.
Defecation function 1 year after surgery 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.
3-year locoregional recurrence rate 3 years after surgery 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).
Trial Locations
- Locations (1)
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China