NCT05682794

Brief Summary

The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

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

January 1, 2014

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

8.8 years

First QC Date

December 27, 2022

Last Update Submit

December 27, 2022

Conditions

Keywords

Rectal cancertaTMELocal recurrence

Outcome Measures

Primary Outcomes (2)

  • Overall survival rate

    5 years after the surgery

  • disease-free survival ratev

    5 years after the surgery

Secondary Outcomes (5)

  • Local recurrence rate

    3 years after the surgery

  • Cancer special survival rate

    5 years after the surgery

  • Quality of the mesorectum specimen

    30 days after the surgery

  • CRM status

    30 days after the surgery

  • DRM status

    30 days after the surgery

Study Arms (2)

taTME

patients who underwent transanal total mesorectal excision

Procedure: transanal total mesorectal excision

laTME

patients who underwent laparoscopic total mesorectal excision

Interventions

transanal TME

Also known as: laparoscopic total mesorectal excision
taTME

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Low-mid rectal cancer within Stage III.

You may qualify if:

  • Age between 18 and 80 years old
  • Confirmed rectal adenocarcinoma cancer pathologically
  • Tumor location ≦ 12 cm from the anal margin
  • Willing and able to provide written informed consent for participation in this study

You may not qualify if:

  • Distant metastasis before surgery
  • More than one colorectal tumor at diagnosis
  • Familial adenomatous polyposis
  • Recurrent rectal cancer
  • Undergo transanal minimally invasive surgery
  • Undergo palliative treatment
  • Undergo emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li Z, Liu H, Luo S, Hou Y, Zhou Y, Zheng X, Zhang X, Huang L, Zeng Z, Kang L. Long-term oncological outcomes of transanal versus laparoscopic total mesorectal excision for mid-low rectal cancer: a retrospective analysis of 2502 patients. Int J Surg. 2024 Mar 1;110(3):1611-1619. doi: 10.1097/JS9.0000000000000992.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Liang Kang

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

January 1, 2014

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 12, 2023

Record last verified: 2022-12