An interventional study of taTME and abdTME in Survival, Postoperative Morbidity and Mortality, sponsored by Cantonal Hospital of St. Gallen. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Cantonal Hospital of St. Gallen · Not applicable, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 300 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with rectal cancer receiving transanal TME
Procedure: taTME
patients with rectal cancer receiving open, laparoscopic or robotic TME
Procedure: abdTME
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.
Also known as: transanal total mesorectal excision
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
Also known as: abdominal total mesorectal excision
Overall survival
time from surgery to end of follow-up or death
Time frame: 60 months
cancer-specific survival
time from surgery to end of follow-up or death due to rectal cancer
Time frame: 60 months
disease-specific survival
time from surgery to end of follow-up or death due to or recurrence of rectal cancer
Time frame: 60 months
positive resection margin
tumor extending to the resection margin in pathological examination (R0, R1)
Time frame: 30 days
Quirke Score
Quality of mesorectal excision in pathological examination (Good, modest, bad)
Time frame: 30 days
circular resection margin (CRM)
size of circular resection margin (mm) in pathological examination
Time frame: 30 days
number of lymph nodes
number of lymph nodes in pathological examination
Time frame: 30 days
postoperative morbidity
Number of patients with postoperative complications (bleeding, anastomotic leakage, ileus, sacral infect, fistula, other surgical complications). The complications will be classified according the Clavien-Dindo-Classification
Time frame: 30 days
postoperative 90-day mortality
Number of patients who die in the first 90 days after surgery
Time frame: 90 days
relapse-free survival
local recurrence
Time frame: 60 months
recurrence-free survival
local or systemic recurrence
Time frame: 60 months
Plan to share: No
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Cantonal Hospital of St. Gallen