Chinese TaTME Registry Collaborative
- Conditions
- Rectal Cancer
- Registration Number
- NCT03416699
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- malignant or benign neoplasms of the rectum
- the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- tolerable to surgery
- be able to understand and willing to participate in this registry with signature
- patients requiring emergency surgery such as obstruction，perforation and bleeding
- tumor involving adjacent organs, anal sphincter, or levator ani muscle
- muti-focal colorectal cancer
- preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
- history of inflammatory bowel disease or familial adenomatous polyposis
- can not tolerate the surgery
- history of serious mental illness
- pregnancy or lactating women
- preoperative uncontrolled infection
- the researchers believe the patients should not enrolled in
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive rate of circumferential resection margin (CRM) of the specimens 10 days after surgery Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.
The grade score of the specimens integrity 10 days after surgery shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
- Secondary Outcome Measures
Name Time Method the severity of postoperative complication assessed by Clavien Dindo grade 30 days after surgery the severity of postoperative complication after transanal total mesorectal assessed by Clavien Dindo grade
overall survival rate 3-year after surgery show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
disease free survival rate 3-year after surgery show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
local recurrence rate 3 years after surgery show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
the incidence of postoperative complications 30 days after surgery the incidence of postoperative complications after transanal total mesorectal excision.
the grade of anastomotic leakage 30 days after surgery the grade of anastomotic leakage for patients who develop anastomotic leakage after transanal total mesorectal excision assessed by the grading system proposed by International Study Group of Rectal Cancer (ISREC).
Trial Locations
- Locations (1)
Beijing Friendship Hospital
🇨🇳Beijing, China