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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:
Researchers will compare two surgical strategies:
Both groups will undergo robotic surgery following total mesorectal excision (TME) principles.
Participants will:
The trial aims to provide high-level evidence for optimizing surgical strategies in mid/low rectal cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMA-LN Preservation | Active Comparator | 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). |
|
| IMA-LN Dissection | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dissection of Inferior Mesenteric Artery Root Lymph Node | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after surgery |
| Urinary function |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complication rate | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Xu, Prof. | Contact | +86 13501984869 | xujmin@aliyun.com | |
| Qingyang Feng, M.D. | Contact | 86-021-64041990 | fqy198921@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Xu, Prof. | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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.
Data will be available from the publication date until 36 months post-publication.
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.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Preservation of Inferior Mesenteric Artery Root Lymph Node | Procedure | 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). |
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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.
| 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. | 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. | 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. | 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). | 3 years after surgery |
| 30 days after surgery |
| Open conversion rate | Percentage of patients converting to open surgery. | 30 days after surgery |
| Operative time | Time from skin incision to wound closure, recorded in minutes. | 30 days after surgery |
| Estimated intraoperative blood loss | Calculated as suctioned blood volume + gauze weight change, recorded in ml. | 30 days after surgery |
| Blood transfusion rate | Percentage of patients with any of transfusion intraoperative or within 30 days postoperatively. | 30 days after surgery |
| Protective stoma rate | Percentage of patients with any of protective stoma, including terminal ileostomy or colostomy. | 30 days after surgery |
| Macroscopic completeness of resection | Percentage of classification as complete, near-complete, or incomplete, according to previous report (Nagtegaal ID, et al. J Clin Oncol 2002; 20: 1729-34.) | 30 days after surgery |
| Proximal resection margin distance | Distance from tumor upper edge to proximal resection margin, recorded in cm. | 30 days after surgery |
| Distal resection margin distance | Distance from tumor lower edge to distal resection margin (excludes abdominoperineal resection), recorded in cm. | 30 days after surgery |
| Distal resection margin positivity rate | Percentage of patients with positive distal resection margin (excluding abdominoperineal resection). | 30 days after surgery |
| Circumferential resection margin positivity rate | Percentage of patients with circumferential resection margin ≤1 mm. | 30 days after surgery |
| Number of lymph nodes harvested | Total number of lymph nodes detected from the specimen. | 30 days after surgery |
| Number of No.253 lymph nodes harvested | Number of No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen. | 30 days after surgery |
| Number of positive lymph nodes | Number of positive lymph nodes detected from the specimen. | 30 days after surgery |
| Number of positive No. 253 lymph nodes | Number of positive No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen. | 30 days after surgery |
| Postoperative mortality rate | Percentage of patients died within 30 days postoperatively. | 30 days after surgery |
| 30-day readmission rate | Percentage of patients with rehospitalization for disease-related causes within 30 days postoperatively. | 30 days after surgery |
| 30-day reoperation rate | Percentage of patients with unplanned surgery for disease-related causes within 30 days postoperatively. | 30 days after surgery |
| Time to first flatus | Time from surgery completion to first passage of gas/stoma bag inflation, recorded in hour. | 30 days after surgery |
| Time to first liquid diet | Time from surgery completion to first liquid intake, recorded in hour. | 30 days after surgery |
| Time to first semi-solid diet | Time from surgery completion to first semi-solid intake, recorded in hour. | 30 days after surgery |
| Time to first defecation | Time from surgery completion to first bowel movement, recorded in hour. | 30 days after surgery |
| Time to first autonomous urination | Time from surgery completion to first autonomous urination, recorded in hour. | 30 days after surgery |
| Postoperative hospital stay | Time from surgery completion to discharge, including readmissions within 30 days postoperatively, recorded in day. | 30 days after surgery |
| 3-year overall survival rate | The 3-year overall survival (OS) rate was defined as the percentage of patients with no death within 3 years postoperatively. | 3 years after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |