Rectal CancerREAL2NCT06956976
Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
A study testing Dissection of Inferior Mesenteric Artery Root Lymph Node and Preservation of Inferior Mesenteric Artery Root Lymph Node in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Dissection of Inferior Mesenteric Artery Root Lymph Node and Preservation of Inferior Mesenteric Artery Root Lymph Node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,596 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- No history of other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ)
- Suitable for robotic surgery
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- American Society of Anesthesiologists (ASA) grade >III
- Pregnancy or lactation
- Preoperative short-course radiotherapy
- Inability of the patient/family to comprehend the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Jianmin Xu, Prof., +86-021-64041990, xujmin@aliyun.com
Qingyang Feng, Dr., +86-021-64041990, fqy198921@163.com
About this study
Official 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
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.
Read the 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:
- 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.
- Conditions
- Rectal Cancer
- Being tested
- Dissection of Inferior Mesenteric Artery Root Lymph Node, Preservation of Inferior Mesenteric Artery Root Lymph Node
- Keywords
- Robotic Surgery, No. 253 lymph node, lymph node dissection, disease-free survival
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissection of Inferior Mesenteric Artery Root Lymph NodeProcedure or surgery
Also called IMA-LN Dissection
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).
Preservation of Inferior Mesenteric Artery Root Lymph NodeProcedure or surgery
Also called IMA-LN Preservation
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Preservation of Inferior Mesenteric Artery Root Lymph Node |
| 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). Receives: Procedure: Dissection of Inferior Mesenteric Artery Root Lymph Node |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years after surgery
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, Prof., Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956976
- Sponsor's protocol ID
- REAL2
- Acronym
- REAL2
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06956976
- Acronym / sponsor ID
- REAL2 / REAL2
- Conditions
- Rectal Cancer
- Keywords
- Robotic Surgery, No. 253 lymph node, lymph node dissection, disease-free survival
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,596 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMA-LN Preservation | Active comparator | Procedure: Preservation of Inferior Mesenteric Artery Root Lymph NodePatients 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 | Procedure: Dissection of Inferior Mesenteric Artery Root Lymph NodePatients 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissection of Inferior Mesenteric Artery Root Lymph NodeAlso: IMA-LN DissectionPatients 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). | Procedure or surgery | IMA-LN Dissection |
| Preservation of Inferior Mesenteric Artery Root Lymph NodeAlso: IMA-LN PreservationPatients 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). | Procedure or surgery | IMA-LN Preservation |
Primary outcome
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).
6 secondary outcomes
30-day postoperative complication rate
Time frame: 30 days after surgery
Urinary function
Time frame: 1 year after surgery
Male sexual function
Time frame: 1 year after surgery
Female sexual function
Time frame: 1 year after surgery
Defecation function
Time frame: 1 year after surgery
3-year locoregional recurrence rate
Time frame: 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianmin Xu, Prof. study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissection of Inferior Mesenteric Artery Root Lymph Node and Preservation of Inferior Mesenteric Artery Root Lymph Node in people with Rectal Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Xu, Prof. (+86 13501984869, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.