NCT04098471Recruiting
Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer
Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 19 Sept 2019
- Start date
- 1 Oct 2021
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT04098471
What you commit to
- Study type: Interventional
- Planned participants: 168
- From 1 Oct 2021 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum.
Other illness
- History of other malignant tumors within the past 5 years.
- Severe psychiatric disorders.
- Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment.
Other
- 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.
- Current participation in another clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.