The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

Inclusion criteria

• Newly diagnosed patients, aged 18 to 75 years;
• Pathologically confirmed rectal adenocarcinoma;
• Distance of the lower margin of the rectal tumor lesion from the anal margin <15cm;
• High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules;
• Exclusion of patients with non-local recurrence or distant metastases;
• Absence of synchronous colorectal multiple primary cancers;
• Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
• The study physician assessed no difficulty in sphincter preservation;
• patients and their families will be willing to participate in this study and provide written informed consent.

Exclusion criteria

• Patients with concurrent other malignancies or a history of malignant tumors in the past;
• Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
• Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
• Patients with poor anal function or fecal incontinence before surgery;
• Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
• Patients recently diagnosed with other malignancies;
• Patients with ASA grade ≥ IV and/or ECOG performance status score > 2;
• Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
• Patients with a history of severe mental illness;
• Pregnant or lactating women;
• Patients with uncontrolled infections before surgery;
• Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.