Chinese TaTME Registry Collaborative

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416699
• Other study ID #: CTRC
• Status: Recruiting
• Phase: N/A
• First received: January 1, 2018
• Last updated: January 24, 2018
• Start date: November 15, 2017
• Est. completion date: November 15, 2021

Study information

• Verified date: January 2018
• Source: Beijing Friendship Hospital
• Contact: Hongwei Yao, M.D.
• Phone: +8613611015609
• Email: yaohongwei[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing

Sponsors (36)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	the incidence of postoperative complications	the incidence of postoperative complications after transanal total mesorectal excision.	30 days after surgery
Secondary	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
Secondary	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