Chinese TaTME Registry Collaborative

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状态招聘中

赞助商

Beijing Friendship Hospital

合作者

Ruijin Hospital

Peking Union Medical College Hospital

Beijing Cancer Hospital

The First Affiliated Hospital of Dalian Medical University

Shengjing Hospital

Huashan Hospital

Guangdong Dongguan Kanghua Hospital

Guangdong Provincial People's Hospital

Nanfang Hospital of Southern Medical University

Nanchong Central Hospital

Sino-Japanese Friendship Hospital of Jilin University

Koo Foundation Sun Yat-Sen Cancer Center

Shangdong Linzi District People's Hospital

Peking University People's Hospital

Nantong University

Liaoning Tumor Hospital & Institute

First Hospital of Jilin University

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

The First Affiliated Hospital of Nanchang University

Nanjing PLA General Hospital

The First Affiliated Hospital of Guangzhou Medical University

The First Affiliated Hospital of Xiamen University

Sichuang Zigong First People's Hospital

Beijing Chao Yang Hospital

Peking University Third Hospital

Jinhua Central Hospital

Beijing Hospital

The First Affiliated Hospital of Zhengzhou University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Tianjin Medical University General Hospital

LanZhou University

Chinese PLA General Hospital

Cancer Hospital of Guizhou Province

First Hospital of China Medical University

First Affiliated Hospital of Chongqing Medical University

临床试验: NCT03416699

BioSeek: NCT03416699

关键词

抽象

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.

日期

最后验证:	12/31/2017
首次提交:	12/31/2017
提交的预估入学人数:	01/23/2018
首次发布:	01/30/2018
上次提交的更新:	01/23/2018
最近更新发布:	01/30/2018
实际学习开始日期:	11/14/2017
预计主要完成日期:	11/14/2018
预计完成日期:	11/14/2021

状况或疾病

Rectal Cancer

相

资格标准

有资格学习的性别	All
取样方式	Non-Probability Sample
接受健康志愿者	是
标准	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

结果

主要结果指标

1. 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.

2. 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.

次要成果指标

1. 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.

2. 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.

3. 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.

4. the incidence of postoperative complications [30 days after surgery]

the incidence of postoperative complications after transanal total mesorectal excision.

5. 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

6. 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).

Chinese TaTME Registry Collaborative

关键词

neoplasms

hypertrophy

obesity

抽象

日期

状况或疾病

相

资格标准

结果

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