Abdominal or Transanal TME for Rectal Cancer Therapy

Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Mortality; Survival; Postoperative Morbidity
• Intervention / Treatment: Procedure: taTME; Procedure: abdTME

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukas Marti, Dr. med.; Phone Number: +41 71 494 13 39; Email: lukas.marti@kssg.ch
• Study Contact Backup: Name: Yanic Ammann; Phone Number: +41 71 494 93 53; Email: yanic.ammann@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Recruiting
      • Department of surgery, Cantonal hospital of St. Gallen
      • Contact: Lukas Marti, M D; Phone Number: 0041 71 41-71-494-1339; Email: lukas.marti@kssg.ch
      • Principal Investigator: Lukas Marti, M D
      • Sub-Investigator: Kathrin Müller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transanal TME (taTME); patients with rectal cancer receiving transanal TME	Procedure: taTME; 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.; Other Names: transanal total mesorectal excision
Active Comparator: abdominal TME (abTME); 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 an abdominal Approach.; Other Names: abdominal total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Study Director: Lukas Marti, Dr. med., Leitender Arzt, Chirurige KSSG

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rectal Cancer; TME; local recurrence; transanal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Rectal Neoplasms
• Other Study ID Numbers: TMEabdVSta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No