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Clinical Trials/NCT04969107
NCT04969107
Recruiting
Not Applicable

Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study

Cantonal Hospital of St. Gallen1 site in 1 country300 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Survival
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
300
Locations
1
Primary Endpoint
disease-specific survival
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.

Detailed Description

Rectal cancer accounts for 3.8% of all new cancer diagnosis and for 3.4% of all cancer-related deaths in the world in 2020. Regarding treatment of rectal cancer, it is essential to perform surgery along the anatomical and embryological planes. This technique called total mesorectal excision (TME) reduces the local recurrence rate and improves the survival. Since the early 2000, TME has changed from open to laparoscopic approach due to better results in short-term outcome. Nevertheless, oncological benefits are modest. In 2009 the first ever transanal TME (taTME) war performed. This novel technique combines abdominal with transanal dissection. Because the distal part of the rectum is approached from below, a better visualization of the mesorectal plane resulting in higher rate of free CRM and of complete TME specimen grade (Quirke Score) can be accomplished. However, taTME remains a hot topic in the current scientific literature. In Norway and the Netherlands a higher rate of anastomotic leakage as well as a higher rate of local recurrence (9.5%) with multifocal growth pattern were described.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lukas Marti

Dr. med. Lukas Marti, Leitender Arzt Chirurgie

Cantonal Hospital of St. Gallen

Eligibility Criteria

Inclusion Criteria

  • all patients receiving elective total mesorectal excision

Exclusion Criteria

  • diagnosis other than rectal cancer
  • partial mesorectal excision
  • discontinuity resection (no anastomosis)
  • incomplete Staging
  • metastatic cancer
  • lack of follow-up
  • decline of a retrospective data Analysis
  • age under 18 years

Outcomes

Primary Outcomes

disease-specific survival

Time Frame: 60 months

time from surgery to end of follow-up or death due to or recurrence of rectal cancer

Overall survival

Time Frame: 60 months

time from surgery to end of follow-up or death

cancer-specific survival

Time Frame: 60 months

time from surgery to end of follow-up or death due to rectal cancer

Secondary Outcomes

  • positive resection margin(30 days)
  • relapse-free survival(60 months)
  • number of lymph nodes(30 days)
  • postoperative 90-day mortality(90 days)
  • recurrence-free survival(60 months)
  • postoperative morbidity(30 days)
  • Quirke Score(30 days)
  • circular resection margin (CRM)(30 days)

Study Sites (1)

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