This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision(LaTME).
Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present,surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety,efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients undergo transanal total mesorectal excision.(assisted by laparoscopy to control the IMA)
Patients undergo Laparoscopic total mesorectal excision.
Ruijin Hospital North
Shanghai, Shanghai Municipality, China
Circumferential resection margin (CRM)
Positive rate of circumferential resection margin (pathological assessment)
Time frame: 14 days after surgery
Completeness of mesorectum
Pathological assessment of completeness of the TME specimen(complete, near
Time frame: 14 days after surgery
Lymph node detection
Lymph nodes harvested(numbers)
Time frame: 14 days after surgery
Distal safety margin
Length of distal margin (millimeter,mm)
Time frame: 14 days after surgery
Operative time
Operative time(minutes)
Time frame: Intraoperative
Intraoperative blood loss
Estimated blood loss(milliliters,ml)
Time frame: Intraoperative
Length of stay
Duration of hospital stay(days after surgery)
Time frame: 1-30 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)
Time frame: 1-14 days after surgery
Early morbidity rate
Morbidity rate 30 days after surgery
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Time frame: 30 days
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 and the day of discharge
Time frame: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Time frame: 60 months after surgery