Rectal Cancer
Conditions
Keywords
TaTME, Rectal cancer, Laparoscopic Surgery
Brief summary
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）.
Detailed description
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.
Interventions
PROCEDURETransanal total mesorectal excision
Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
Patients undergo Laparoscopic total mesorectal excision.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years \< age \< 80 years * Body mass index (BMI) \<30 kg/m2 * Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection) * Pathological rectal carcinoma * Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history * Tumor size of 5 cm or less * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent
Exclusion criteria
* Requiring a Mile's procedure * Fecal incontinence * History of inflammatory bowel disease * Pregnant woman or lactating woman * Severe mental disease * Intolerance of surgery for severe comorbidities * Previous abdominal surgery * Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer * Requirement of simultaneous surgery for other disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circumferential resection margin (CRM) | 14 days after surgery | Positive rate of circumferential resection margin (pathological assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
| Distal safety margin | 14 days after surgery | Length of distal margin （millimeter，mm） |
| Operative time | Intraoperative | Operative time（minutes） |
| Intraoperative blood loss | Intraoperative | Estimated blood loss（milliliters，ml） |
| Length of stay | 1-30 days after surgery | Duration of hospital stay（days after surgery） |
| Completeness of mesorectum | 14 days after surgery | Pathological assessment of completeness of the TME specimen（complete, near |
| Early morbidity rate | 30 days | Morbidity rate 30 days after surgery |
| Pain score | 1-3 days after surgery | 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 |
| 3-year disease free survival rate | 36 months after surgery | 3-year disease free survival rate |
| 5-year overall survival rate | 60 months after surgery | 5-year overall survival rate |
| Postoperative recovery course | 1-14 days after surgery | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） |
Countries
China
Outcome results
None listed