A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
Currently, laparoscopic total mesorectal excision (TME) has become the standard procedure for treating middle and distal rectal cancer. Anastomotic leakage has always been one of the serious complications of TME surgery, and Anastomotic leakage not only increases the hospital expenses, but also brings physical discomfort and psychological pain to the patients. Furthermore, anastomotic leakage is associated with a heightened risk of anastomotic stenosis, compromised bowel function, delayed initiation of postoperative adjuvant therapy, increased local recurrence rates post-surgery, and diminished long-term survival outcomes. A report from the Netherlands indicates that anastomotic leakage serves as an independent prognostic factor for overall survival in patients diagnosed with rectal cancer. Prior studies have documented the incidence of anastomotic leakage to range between 3.6% and 21%, attributable to a confluence of various factors including technical complications, oncological considerations, and the patient\'s overall health status. Among these determinants, aspects such as blood supply adequacy, tension at the site of anastomosis, tissue quality, and anatomical positioning of the rectum are widely recognized as significant risk factors for developing anastomotic leaks.Currently, several strategies are employed to mitigate the incidence of anastomotic leakage, including preoperative proctocolectomy, anal decompression placement, vertical transverse resection of the rectum, and anastomotic reinforcement techniques. In our clinical practice, we have innovatively integrated multiple approaches: (1) preservation of the left colic artery (LCA); (2) high-level resection of the inferior mesenteric vein (IMV); (3) standardized mobilization of the splenic flexure along with left lateral colon; (4) multi-plane dissection of mesorectal flaps; and (5) selective reinforcement at the anastomosis. Our findings indicate that multi-technology integrated total mesorectal excision (MTI-TME) significantly reduces both preventive stoma rates and incidences of anastomotic leakage compared to conventional total mesorectal excision (C-TME), . However, there remains a lack of robust evidence-based medicine supporting MTI-TME\'s advantages in treating middle and distal rectal cancer; further research is urgently needed to provide additional clinical evidence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
anastomotic leakage rate
Time frame: 1 year
Operation time
Time frame: During surgery
intraoperative blood loss
Time frame: During surgery
3-year overall suvival rate
Time frame: 3 years
local recurrance rate
Time frame: 3 years
3-year disease-free survival rate
Time frame: 3 years
3-year mortality rate
Time frame: 3 years
postoperative quality of life
Postoperative quality of life will be evaluated by EORTC QLQ C30 Questionnaire
Time frame: 3 years
intestinal exhaust time
Time frame: 1 year
postoperative pain
Postoperative pain will be assessed by numerical rating scale (NES).
Time frame: 1 year
colostomy rate
Time frame: 1 year
hospital stay
Time frame: 1 year
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hospital cost
Time frame: 1 year