Abdominal or Transanal TME for Rectal Cancer Therapy

Cantonal Hospital of St. Gallen

Status: Enrolling

Conditions: Mortality; Survival; Postoperative Morbidity; Recurrence

Treatments: Procedure: abdTME; Procedure: taTME

Study type: Interventional

Funder types: Other

Identifiers

NCT04969107

TMEabdVSta

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

transanal TME (taTME)

Active Comparator group

Description:

patients with rectal cancer receiving transanal TME

Treatment:

Procedure: taTME

abdominal TME (abTME)

Active Comparator group

Description:

patients with rectal cancer receiving open, laparoscopic or robotic TME

Treatment:

Procedure: abdTME