Chinese TaTME Registry Collaborative

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Hongwei Yao, M.D.; Phone Number: +8613611015609; Email: yaohongwei@ccmu.edu.cn
• Study Contact Backup: Name: Yongbo An, M.D.; Phone Number: +8615600682616; Email: 15600682616@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with middle-lower rectal neoplasms who are suitable and willing to accept TaTME procedure and also agree with the registry

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of circumferential resection margin (CRM) of the specimens	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.	10 days after surgery
The grade score of the specimens integrity	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.	10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local recurrence rate	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.	3 years after surgery
disease free survival rate	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.	3-year after surgery
overall survival rate	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.	3-year after surgery
the incidence of postoperative complications	the incidence of postoperative complications after transanal total mesorectal excision.	30 days after surgery
the severity of postoperative complication assessed by Clavien Dindo grade	the severity of postoperative complication after transanal total mesorectal assessed by Clavien Dindo grade	30 days after surgery
the grade of anastomotic leakage	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).	30 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; LanZhou University; Peking University People's Hospital; Peking Union Medical College Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; Peking University Third Hospital; Huashan Hospital; Peking University Cancer Hospital & Institute; Shengjing Hospital; Nanfang Hospital of Southern Medical University; Ruijin Hospital; Beijing Chao Yang Hospital; Beijing Hospital; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; The First Affiliated Hospital of Guangzhou Medical University; The First Hospital of Jilin University; Tianjin Medical University General Hospital; First Hospital of China Medical University; Nantong University; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Jinhua Central Hospital; Liaoning Tumor Hospital & Institute; First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Dalian Medical University; Koo Foundation Sun Yat-Sen Cancer Center; The First Affiliated Hospital of Xiamen University; Nanjing PLA General Hospital; Sino-Japanese Friendship Hospital of Jilin University; Cancer Hospital of Guizhou Province; Nanchong Central Hospital; Guangdong Dongguan Kanghua Hospital; Shangdong Linzi District People's Hospital; Sichuang Zigong First People's Hospital

Publications and helpful links

General Publications

• Li Q, Yang X, Teng Q, Guo Q, Qin L, Lv Z, Zhou D, Ren M. Reasonable Collocation of Two Different Functional 3D Laparoscopes May Improve the Efficiency of Transanal Total Mesorectal Excision Surgery Using a Synchronous Two-Team Approach? J Laparoendosc Adv Surg Tech A. 2022 Jul 22. doi: 10.1089/lap.2022.0326. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2017
• Primary Completion (ANTICIPATED): November 15, 2018
• Study Completion (ANTICIPATED): November 15, 2021

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Rectal Cancer; Transnal Total Mesorectal Excision
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CTRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No