The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2021-10-01
Last updated
2026-07-28
Condition(s) studied
Rectal Cancer
Investigational drug(s) / intervention(s)
transanal local excision following radiotherapyTME
transanal local excision following radiotherapy: transanal local excision following radiotherapy
TME: Total mesorectal excision
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
local recurrance rate — 3 years
Trial sites (1)
Facility
City
Region
Status
Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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