Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site

NCT ID: NCT03253302

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-12-31

Brief Summary

At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• adenocarcinoma of the rectum by biopsy
• the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
• tumor diameter less than 4cm
• baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
• tolerable to surgery
• be able to understand and willing to participate in this trial with signature

Exclusion Criteria

• history of malignant colorectal neoplasia
• recent diagnosis with other malignancies
• 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
• participating in other clinical trails
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Ruijin Hospital

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

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhongtao Zhang

assistant dean, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CR-TaTME

Identifier Type: -

Identifier Source: org_study_id