Chinese TaTME Registry Collaborative

Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03416699

Enrollment

300

Registered

2018-01-31

Start date

2017-11-15

Completion date

2021-11-15

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Transnal Total Mesorectal Excision, Rectal Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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).
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
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.

Countries

China

Contacts

Primary ContactHongwei Yao, M.D.

yaohongwei@ccmu.edu.cn+8613611015609

Backup ContactYongbo An, M.D.

15600682616@163.com+8615600682616

Outcome results