Chinese TaTME Registry Collaborative

NCT ID: NCT03416699

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2021-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Keywords

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Transnal Total Mesorectal Excision Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Guangdong Dongguan Kanghua Hospital

UNKNOWN

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Nanchong Central Hospital

OTHER_GOV

Sponsor Role collaborator

Sino-Japanese Friendship Hospital of Jilin University

UNKNOWN

Sponsor Role collaborator

Koo Foundation Sun Yat-Sen Cancer Center

OTHER

Sponsor Role collaborator

Shangdong Linzi District People's Hospital

UNKNOWN

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Nantong University

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Nanjing PLA General Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

Sichuang Zigong First People's Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Cancer Hospital of Guizhou Province

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

assistant dean, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongwei Yao, M.D.

Role: CONTACT

Phone: +8613611015609

Email: [email protected]

Yongbo An, M.D.

Role: CONTACT

Phone: +8615600682616

Email: [email protected]

Facility Contacts

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Hongwei Yao, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35867023 (View on PubMed)

Other Identifiers

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CTRC

Identifier Type: -

Identifier Source: org_study_id