Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer

Summary

A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Eligibility

Inclusion Criteria:

* Age between 18 and 75 years.
* Histologically confirmed adenocarcinoma by preoperative biopsy.
* Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.
* Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.
* Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.
* No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI.
* Ability to provide written informed consent.

Exclusion Criteria:

* History of other malignant tumors within the past 5 years.
* Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.
* Multiple primary colorectal tumors.
* Pregnant or breastfeeding women.
* Patients with plans for pregnancy.
* Severe psychiatric disorders.
* Previous treatment for rectal cancer, including radiotherapy or chemotherapy.
* Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease.
* Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment.
* Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum.
* Current participation in another clinical trial.

Conditions2

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