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

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About this study

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

Condition
Rectal Cancer
Tested
transanal local excision following radiotherapy, TME
Sponsor
The First Affiliated Hospital with Nanjing Medical University

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Rectal Cancer
  • 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 11

  • 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.

Where

1 site, 1 recruiting

Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.