Abdominal or Transanal TME for Rectal Cancer Therapy
Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
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, 2012
CompletedFirst Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 8, 2023
August 1, 2023
12 years
June 11, 2021
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall survival
time from surgery to end of follow-up or death
60 months
cancer-specific survival
time from surgery to end of follow-up or death due to rectal cancer
60 months
disease-specific survival
time from surgery to end of follow-up or death due to or recurrence of rectal cancer
60 months
Secondary Outcomes (8)
positive resection margin
30 days
Quirke Score
30 days
circular resection margin (CRM)
30 days
number of lymph nodes
30 days
postoperative morbidity
30 days
- +3 more secondary outcomes
Study Arms (2)
transanal TME (taTME)
ACTIVE COMPARATORpatients with rectal cancer receiving transanal TME
abdominal TME (abTME)
ACTIVE COMPARATORpatients with rectal cancer receiving open, laparoscopic or robotic TME
Interventions
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
Eligibility Criteria
You may qualify if:
- all patients receiving elective total mesorectal excision
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of surgery, Cantonal hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lukas Marti, Dr. med.
Leitender Arzt, Chirurige KSSG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Lukas Marti, Leitender Arzt Chirurgie
Study Record Dates
First Submitted
June 11, 2021
First Posted
July 20, 2021
Study Start
January 1, 2012
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
August 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share