Survival, Postoperative Morbidity, Mortality, Recurrence
Conditions
Keywords
TME, Rectal Cancer, transanal, local recurrence
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.
Interventions
PROCEDUREtaTME
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.
PROCEDUREabdTME
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 60 months | time from surgery to end of follow-up or death |
| cancer-specific survival | 60 months | time from surgery to end of follow-up or death due to rectal cancer |
| disease-specific survival | 60 months | time from surgery to end of follow-up or death due to or recurrence of rectal cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of lymph nodes | 30 days | number of lymph nodes in pathological examination |
| postoperative morbidity | 30 days | 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 |
| circular resection margin (CRM) | 30 days | size of circular resection margin (mm) in pathological examination |
| relapse-free survival | 60 months | local recurrence |
| recurrence-free survival | 60 months | local or systemic recurrence |
| postoperative 90-day mortality | 90 days | Number of patients who die in the first 90 days after surgery |
| positive resection margin | 30 days | tumor extending to the resection margin in pathological examination (R0, R1) |
| Quirke Score | 30 days | Quality of mesorectal excision in pathological examination (Good, modest, bad) |
Countries
Switzerland
Contacts
Primary ContactLukas Marti, Dr. med.
Backup ContactYanic Ammann
Outcome results
None listed