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Clinical Trials/NCT05682794
NCT05682794
Completed
Not Applicable

Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

Sun Yat-sen University0 sites2,502 target enrollmentJanuary 2014
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Sun Yat-sen University
Enrollment
2502
Primary Endpoint
disease-free survival ratev
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
October 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yanhong Deng

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

disease-free survival ratev

Time Frame: 5 years after the surgery

Overall survival rate

Time Frame: 5 years after the surgery

Secondary Outcomes

  • Cancer special survival rate(5 years after the surgery)
  • CRM status(30 days after the surgery)
  • DRM status(30 days after the surgery)
  • Quality of the mesorectum specimen(30 days after the surgery)
  • Local recurrence rate(3 years after the surgery)

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