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Chinese TaTME Registry Collaborative

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416699
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Zhongtao Zhang, Beijing Friendship Hospital

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.

Condition or disease
Rectal Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 15, 2021



Primary Outcome Measures :
  1. Positive rate of circumferential resection margin (CRM) of the specimens [ Time Frame: 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 [ Time Frame: 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 Outcome Measures :
  1. local recurrence rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days after surgery ]
    the severity of postoperative complication after transanal total mesorectal assessed by Clavien Dindo grade

  6. the grade of anastomotic leakage [ Time Frame: 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416699


Contacts
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Contact: Hongwei Yao, M.D. +8613611015609 yaohongwei@ccmu.edu.cn
Contact: Yongbo An, M.D. +8615600682616 15600682616@163.com

Locations
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China
Beijing Friendship Hospital Recruiting
Beijing, China
Contact: Hongwei Yao, M.D.    +8613611015609    yaohongwei@medmail.com.cn   
Sponsors and Collaborators
Beijing Friendship Hospital
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
Additional Information:

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Responsible Party: Zhongtao Zhang, assistant dean, professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03416699    
Other Study ID Numbers: CTRC
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongtao Zhang, Beijing Friendship Hospital:
Transnal Total Mesorectal Excision
Rectal Cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases