Clinical trial NCT04969107: Abdominal or Transanal TME for Rectal Cancer Therapy
Official title: Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survival
Postoperative Morbidity
Mortality
Recurrence
Keywords: TME
Rectal Cancer
transanal
local recurrence
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: cancer-specific survival
timeFrame: 60 months
measure: disease-specific survival
timeFrame: 60 months
Secondary outcomes:
measure: positive resection margin
timeFrame: 30 days
measure: Quirke Score
timeFrame: 30 days
measure: circular resection margin (CRM)
timeFrame: 30 days
measure: number of lymph nodes
timeFrame: 30 days
measure: postoperative morbidity
timeFrame: 30 days
measure: postoperative 90-day mortality
timeFrame: 90 days
measure: relapse-free survival
timeFrame: 60 months
measure: recurrence-free survival
timeFrame: 60 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of surgery, Cantonal hospital of St. Gallen
state: Saint Gallen
Study officials:
affiliation: Leitender Arzt, Chirurige KSSG
name: Lukas Marti, Dr. med.
role: STUDY_DIRECTOR
References: