An interventional study of transanal local excision following radiotherapy and TME in Rectal Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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
Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal cancer, transanal endoscopic microsurgery (TEM) has many advantages over total mesorectal excision (TME), such as less trauma, shorter hospitalization time, lower incidence of complications, protection of sexual function and protection of anal function. At present, transanal local excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or chemoradiotherapy should be considered for the presence of positive margin of incision, lymphatic/vascular invasion and poor histological differentiation after transanal local excision. At present, the investigators have consulted a large number of literatures and found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low rectal cancer. Some studies believed that local excision combined with adjuvant therapy is safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more studies need to be carried out to provide guidance for clinical treatment.
In this study, eligible patients will be randomly allocated to operative operation for rectal cancer either by TEM following radiotherapy or TME. 3-years local recurrence rate, 3-years disease free survival rate and 3-years overall survival rate，and postoperative quality of life will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 168 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
Procedure: transanal local excision following radiotherapy
Procedure: TME
transanal local excision following radiotherapy
Total mesorectal excision
local recurrance rate
Time frame: 3 years
3-years overall survival rate
Time frame: 3 years
3-year disease-free survival
Time frame: 3 years
3-year mortality rate
Time frame: 3 years
postoperative quality of life
Measured by Quality of Life Questionnaire "EORTC QLQ-C30 (version 3)"
Time frame: 30 days
complication rate
Time frame: 30 days
perioperative mortality
Time frame: 30 days
R0 resection rate
Time frame: 7 days
operative time
Time frame: 7 days
Intraoperative blood loss
Time frame: 7 days
colostomy rate
Time frame: 7 days
intraoperative blood transfusion
Time frame: 7 days
intestinal exhaust time
Time frame: 7 days
postoperative pain
Postoperative pain was assessed by numerical rating scale (NRS). The pain level is divided into 0 to 10 points, with higher scores indicating stronger pain. 0 point represented painless, 10 point represented severe pain.
Time frame: 30 days after treatment
hospital stay
Time frame: 30 days after treatment
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University