Clinical trial NCT03416699: Chinese TaTME Registry Collaborative
Official title: Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: Transnal Total Mesorectal Excision
Rectal Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Peking Union Medical College Hospital
name: Peking University Cancer Hospital & Institute
name: The First Affiliated Hospital of Dalian Medical University
name: Shengjing Hospital
name: Huashan Hospital
name: Guangdong Dongguan Kanghua Hospital
name: Guangdong Provincial People's Hospital
name: Nanfang Hospital, Southern Medical University
name: Nanchong Central Hospital
name: Sino-Japanese Friendship Hospital of Jilin University
name: Koo Foundation Sun Yat-Sen Cancer Center
name: Shangdong Linzi District People's Hospital
name: Peking University People's Hospital
name: Nantong University
name: Liaoning Cancer Hospital & Institute
name: The First Hospital of Jilin University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: The First Affiliated Hospital of Nanchang University
name: Nanjing PLA General Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: The First Affiliated Hospital of Xiamen University
name: Sichuang Zigong First People's Hospital
name: Beijing Chao Yang Hospital
name: Peking University Third Hospital
name: Jinhua Central Hospital
name: Beijing Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Tianjin Medical University General Hospital
name: LanZhou University
name: Chinese PLA General Hospital
name: Cancer Hospital of Guizhou Province
name: First Hospital of China Medical University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2018-01-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive rate of circumferential resection margin (CRM) of the specimens
timeFrame: 10 days after surgery
measure: The grade score of the specimens integrity
timeFrame: 10 days after surgery
Secondary outcomes:
measure: local recurrence rate
timeFrame: 3 years after surgery
measure: disease free survival rate
timeFrame: 3-year after surgery
measure: overall survival rate
timeFrame: 3-year after surgery
measure: the incidence of postoperative complications
timeFrame: 30 days after surgery
measure: the severity of postoperative complication assessed by Clavien Dindo grade
timeFrame: 30 days after surgery
measure: the grade of anastomotic leakage
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
References:
citation: 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. 2023 Feb;33(2):194-199. doi: 10.1089/lap.2022.0326. Epub 2022 Jul 22.