NCT03416699

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 1, 2018

Last Update Submit

January 24, 2018

Conditions

Rectal Cancer

Keywords

Transnal Total Mesorectal ExcisionRectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Positive rate of circumferential resection margin (CRM) of the specimens

    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.

    10 days after surgery

  • The grade score of the specimens integrity

    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.

    10 days after surgery

Secondary Outcomes (6)

  • local recurrence rate

    3 years after surgery

  • disease free survival rate

    3-year after surgery

  • overall survival rate

    3-year after surgery

  • the incidence of postoperative complications

    30 days after surgery

  • the severity of postoperative complication assessed by Clavien Dindo grade

    30 days after surgery

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35867023DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Hongwei Yao, M.D.

CONTACT

+8613611015609yaohongwei@ccmu.edu.cn

Yongbo An, M.D.

CONTACT

+861560068261615600682616@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant dean, professor

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 31, 2018

Study Start

November 15, 2017

Primary Completion

November 15, 2018

Study Completion

November 15, 2021

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

CN(1)