Rectal Cancer
Conditions
Keywords
Robotic Surgery, No. 253 lymph node, lymph node dissection, disease-free survival
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.
Interventions
PROCEDUREDissection of Inferior Mesenteric Artery Root Lymph Node
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).
PROCEDUREPreservation of Inferior Mesenteric Artery Root Lymph Node
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).
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years and ≤80 years 2. Pathologically confirmed rectal adenocarcinoma by colonoscopic biopsy 3. Tumor located ≤10 cm from the anal verge 4. 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) 5. No distant metastasis (including pelvic, peritoneal, hepatic, pulmonary, cerebral, skeletal, or distant lymph node metastasis) confirmed by imaging 6. Pelvic MRI and/or transrectal ultrasound confirming cT1-T3 N0-1 stage, or ycT1-T3 Nx after neoadjuvant therapy (radiotherapy, chemotherapy, immunotherapy, targeted therapy) 7. No history of other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ) 8. Suitable for robotic surgery 9. Signed informed consent
Exclusion criteria
1. Clinical complete response after radiotherapy, chemotherapy, immunotherapy, or targeted therapy 2. cT1N0 tumors suitable for local excision 3. Emergency surgery required due to acute bowel obstruction, hemorrhage, or perforation 4. Multiple primary colorectal malignancies 5. Familial adenomatous polyposis (FAP), Lynch syndrome, or inflammatory bowel disease 6. Concomitant conditions requiring concurrent colonic resection 7. American Society of Anesthesiologists (ASA) grade \>III 8. Pregnancy or lactation 9. Preoperative short-course radiotherapy 10. Inability of the patient/family to comprehend the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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). |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proximal resection margin distance | 30 days after surgery | Distance from tumor upper edge to proximal resection margin, recorded in cm. |
| Distal resection margin distance | 30 days after surgery | Distance from tumor lower edge to distal resection margin (excludes abdominoperineal resection), recorded in cm. |
| Distal resection margin positivity rate | 30 days after surgery | Percentage of patients with positive distal resection margin (excluding abdominoperineal resection). |
| Circumferential resection margin positivity rate | 30 days after surgery | Percentage of patients with circumferential resection margin ≤1 mm. |
| Number of lymph nodes harvested | 30 days after surgery | Total number of lymph nodes detected from the specimen. |
| Number of No.253 lymph nodes harvested | 30 days after surgery | Number of No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen. |
| Number of positive lymph nodes | 30 days after surgery | Number of positive lymph nodes detected from the specimen. |
| Number of positive No. 253 lymph nodes | 30 days after surgery | Number of positive No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen. |
| Postoperative mortality rate | 30 days after surgery | Percentage of patients died within 30 days postoperatively. |
| Intraoperative complication rate | 30 days after surgery | Percentage of patients with any of intraoperative complications, such as: organ/structural injury (any injury requiring additional surgical repair), device malfunction (leading to procedural delay \>30 minutes), fecal contamination (compromising the sterile surgical field), iatrogenic perforation (tumor or adjacent tissue perforation caused by manipulation), anastomotic complications (intraoperative anastomotic failure/leak requiring repair), tumor residual (tumor not radically resected), major hemorrhage (blood loss \>200 ml at one surgical site), cardiac events (requiring intraoperative intervention), respiratory events (requiring intraoperative intervention). |
| 30-day reoperation rate | 30 days after surgery | Percentage of patients with unplanned surgery for disease-related causes within 30 days postoperatively. |
| Time to first flatus | 30 days after surgery | Time from surgery completion to first passage of gas/stoma bag inflation, recorded in hour. |
| Time to first liquid diet | 30 days after surgery | Time from surgery completion to first liquid intake, recorded in hour. |
| Time to first semi-solid diet | 30 days after surgery | Time from surgery completion to first semi-solid intake, recorded in hour. |
| Time to first defecation | 30 days after surgery | Time from surgery completion to first bowel movement, recorded in hour. |
| Time to first autonomous urination | 30 days after surgery | Time from surgery completion to first autonomous urination, recorded in hour. |
| Postoperative hospital stay | 30 days after surgery | Time from surgery completion to discharge, including readmissions within 30 days postoperatively, recorded in day. |
| 3-year overall survival rate | 3 years after surgery | The 3-year overall survival (OS) rate was defined as the percentage of patients with no death within 3 years postoperatively. |
| 30-day readmission rate | 30 days after surgery | Percentage of patients with rehospitalization for disease-related causes within 30 days postoperatively. |
| Open conversion rate | 30 days after surgery | Percentage of patients converting to open surgery. |
| Operative time | 30 days after surgery | Time from skin incision to wound closure, recorded in minutes. |
| Estimated intraoperative blood loss | 30 days after surgery | Calculated as suctioned blood volume + gauze weight change, recorded in ml. |
| Blood transfusion rate | 30 days after surgery | Percentage of patients with any of transfusion intraoperative or within 30 days postoperatively. |
| Protective stoma rate | 30 days after surgery | Percentage of patients with any of protective stoma, including terminal ileostomy or colostomy. |
| Macroscopic completeness of resection | 30 days after surgery | Percentage of classification as complete, near-complete, or incomplete, according to previous report (Nagtegaal ID, et al. J Clin Oncol 2002; 20: 1729-34.) |
Countries
China
Contacts
Primary ContactJianmin Xu, Prof.
Backup ContactQingyang Feng, M.D.
Outcome results
None listed