Abdominal or Transanal TME for Rectal Cancer Therapy

Not Applicable

Recruiting

• Conditions: Recurrence; Postoperative Morbidity; Survival; Mortality
• Interventions: Procedure: taTME; Procedure: abdTME

• Registration Number: NCT04969107
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transanal TME (taTME)	taTME	patients with rectal cancer receiving transanal TME
abdominal TME (abTME)	abdTME	patients with rectal cancer receiving open, laparoscopic or robotic TME

Primary Outcome Measures

Name	Time	Method
disease-specific survival	60 months	time from surgery to end of follow-up or death due to or recurrence of rectal cancer
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

Secondary Outcome Measures

Name	Time	Method
positive resection margin	30 days	tumor extending to the resection margin in pathological examination (R0, R1)
relapse-free survival	60 months	local recurrence
number of lymph nodes	30 days	number of lymph nodes in pathological examination
postoperative 90-day mortality	90 days	Number of patients who die in the first 90 days after surgery
recurrence-free survival	60 months	local or systemic recurrence
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
Quirke Score	30 days	Quality of mesorectal excision in pathological examination (Good, modest, bad)

Trial Locations

Locations (1)

Department of surgery, Cantonal hospital of St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland