Clinical trial · Interventional
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dissection of the No.253 lymph node | Procedure | — | UNRESOLVED |
| Omitting the dissection of the No.253 lymph node | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Omitting dissection of the No.253 lymph node
- description
- Perform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery.
- interventionNames
- Procedure: Omitting the dissection of the No.253 lymph node
- type
- ACTIVE_COMPARATOR
- label
- Dissection of the No.253 lymph node
- description
- Perform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery.
- interventionNames
- Procedure: Dissection of the No.253 lymph node
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age between 18-75 years. 2. Colonic biopsy pathology confirms adenocarcinoma. 3. The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis. 4. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3. 5. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery. 6. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three. 7. Strong willingness for surgery and signed informed consent. Exclusion Criteria: 1. Previous history of malignant colorectal tumors. 2. Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma. 3. Imaging diagnosis of distant metastasis. 4. Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions. 5. Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery. 6. Extensive lesions not amenable to R0 resection. 7. Diagnosed with other malignancies within the past five years. 8. ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2. 9. Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery. 10. History of severe mental illness. 11. Pregnant or breastfeeding women.
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Mingguang Zhang, Shuohui Dong, Haitao Zhou et al. · BMJ Open · Sep 25, 2026 · PMID 42790919 pubmed