Simple Transanal Local Excision,Transanal Local Excision Following Radiotherapy Versus Total Mesorectum Excision for the Treatment of the Ultra-low T2N0M0 Rectal Cancer

2019-09-26 05:42:38 | BioPortfolio


A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision,transanal local excision 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 local excision (TLE) 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 simple TLE,TLE following radiotherapy or TME. 5-years disease free survival rate, 5-years overall survival rate,local recurrence 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.

Study Design


Rectal Cancer


transanal local excision following radiotherapy


Not yet recruiting


The First Affiliated Hospital with Nanjing Medical University

Results (where available)

View Results


Published on BioPortfolio: 2019-09-26T05:42:38-0400

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Medical and Biotech [MESH] Definitions

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

A specialized form of transanal endoscopic surgery for microscopically controlled operations in the RECTUM.

Surgical excision of one or more lymph nodes. Its most common use is in cancer surgery. (From Dorland, 28th ed, p966)

A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.

The edges of tissue removed in a surgery for assessment of the effectiveness of a surgical procedure in achieving the local control of a neoplasm and the adequacy of tumor removal. When the margin is negative or not involved by tumor (e.g., CANCER) it suggests all of the tumor has been removed by the surgery.

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