About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
transanal local excision following radiotherapy
Procedure/Surgerytransanal local excision following radiotherapy
TME
Procedure/SurgeryTotal mesorectal excision
Treatment groups
Trial outcomes
Primary outcomes
local recurrance rate
Secondary outcomes
3-years overall survival rate
3-year disease-free survival
3-year mortality rate
postoperative quality of life
Measured by Quality of Life Questionnaire "EORTC QLQ-C30 (version 3)"
Sponsors and contacts
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