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NCT Number: NCT06956976

Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Does preserving IMA-LN achieve non-inferior 3-year disease-free survival (DFS) compared to IMA-LN dissection?
  • 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:

  • 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.
  • 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:

  • Be randomly assigned to either the preservation or dissection group. Receive standardized preoperative evaluations (imaging, biopsies) and postoperative follow-up for 3 years.
  • Undergo regular clinical assessments, including tumor marker tests, imaging (CT/MRI), colonoscopy, and quality-of-life questionnaires (evaluating urinary/sexual/defecation function).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Other names: IMA-LN Dissection

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).

Other names: IMA-LN Preservation

Primary outcomes

  1. 3-year disease-free survival rate

    Time frame: 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 outcomes

  1. 30-day postoperative complication rate

    Time frame: 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

  2. Urinary function

    Time frame: 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.

  3. Male sexual function

    Time frame: 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.

  4. Female sexual function

    Time frame: 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.

  5. Defecation function

    Time frame: 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.

  6. 3-year locoregional recurrence rate

    Time frame: 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).

Other outcomes

  1. Intraoperative complication rate

    Time frame: 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).

  2. Open conversion rate

    Time frame: 30 days after surgery

    Percentage of patients converting to open surgery.

  3. Operative time

    Time frame: 30 days after surgery

    Time from skin incision to wound closure, recorded in minutes.

  4. Estimated intraoperative blood loss

    Time frame: 30 days after surgery

    Calculated as suctioned blood volume + gauze weight change, recorded in ml.

  5. Blood transfusion rate

    Time frame: 30 days after surgery

    Percentage of patients with any of transfusion intraoperative or within 30 days postoperatively.

  6. Protective stoma rate

    Time frame: 30 days after surgery

    Percentage of patients with any of protective stoma, including terminal ileostomy or colostomy.

  7. Macroscopic completeness of resection

    Time frame: 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.)

  8. Proximal resection margin distance

    Time frame: 30 days after surgery

    Distance from tumor upper edge to proximal resection margin, recorded in cm.

  9. Distal resection margin distance

    Time frame: 30 days after surgery

    Distance from tumor lower edge to distal resection margin (excludes abdominoperineal resection), recorded in cm.

  10. Distal resection margin positivity rate

    Time frame: 30 days after surgery

    Percentage of patients with positive distal resection margin (excluding abdominoperineal resection).

  11. Circumferential resection margin positivity rate

    Time frame: 30 days after surgery

    Percentage of patients with circumferential resection margin ≤1 mm.

  12. Number of lymph nodes harvested

    Time frame: 30 days after surgery

    Total number of lymph nodes detected from the specimen.

  13. Number of No.253 lymph nodes harvested

    Time frame: 30 days after surgery

    Number of No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen.

  14. Number of positive lymph nodes

    Time frame: 30 days after surgery

    Number of positive lymph nodes detected from the specimen.

  15. Number of positive No. 253 lymph nodes

    Time frame: 30 days after surgery

    Number of positive No. 253 lymph nodes detected at the root of inferior mesenteric artery from the specimen.

  16. Postoperative mortality rate

    Time frame: 30 days after surgery

    Percentage of patients died within 30 days postoperatively.

  17. 30-day readmission rate

    Time frame: 30 days after surgery

    Percentage of patients with rehospitalization for disease-related causes within 30 days postoperatively.

  18. 30-day reoperation rate

    Time frame: 30 days after surgery

    Percentage of patients with unplanned surgery for disease-related causes within 30 days postoperatively.

  19. Time to first flatus

    Time frame: 30 days after surgery

    Time from surgery completion to first passage of gas/stoma bag inflation, recorded in hour.

  20. Time to first liquid diet

    Time frame: 30 days after surgery

    Time from surgery completion to first liquid intake, recorded in hour.

  21. Time to first semi-solid diet

    Time frame: 30 days after surgery

    Time from surgery completion to first semi-solid intake, recorded in hour.

  22. Time to first defecation

    Time frame: 30 days after surgery

    Time from surgery completion to first bowel movement, recorded in hour.

  23. Time to first autonomous urination

    Time frame: 30 days after surgery

    Time from surgery completion to first autonomous urination, recorded in hour.

  24. Postoperative hospital stay

    Time frame: 30 days after surgery

    Time from surgery completion to discharge, including readmissions within 30 days postoperatively, recorded in day.

  25. 3-year overall survival rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianmin Xu, Prof.

CONTACT

[email protected]

+86 13501984869

Qingyang Feng, M.D.

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: REAL2

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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