search
Back to results

Abdominal or Transanal TME for Rectal Cancer Therapy

Primary Purpose

Survival, Postoperative Morbidity, Mortality

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
taTME
abdTME
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survival focused on measuring TME, Rectal Cancer, transanal, local recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of surgery, Cantonal hospital of St. GallenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transanal TME (taTME)

abdominal TME (abTME)

Arm Description

patients with rectal cancer receiving transanal TME

patients with rectal cancer receiving open, laparoscopic or robotic TME

Outcomes

Primary Outcome Measures

Overall survival
time from surgery to end of follow-up or death
cancer-specific survival
time from surgery to end of follow-up or death due to rectal cancer
disease-specific survival
time from surgery to end of follow-up or death due to or recurrence of rectal cancer

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2021
Last Updated
August 7, 2023
Sponsor
Cantonal Hospital of St. Gallen
search

1. Study Identification

Unique Protocol Identification Number
NCT04969107
Brief Title
Abdominal or Transanal TME for Rectal Cancer Therapy
Official Title
Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survival, Postoperative Morbidity, Mortality, Recurrence
Keywords
TME, Rectal Cancer, transanal, local recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transanal TME (taTME)
Arm Type
Active Comparator
Arm Description
patients with rectal cancer receiving transanal TME
Arm Title
abdominal TME (abTME)
Arm Type
Active Comparator
Arm Description
patients with rectal cancer receiving open, laparoscopic or robotic TME
Intervention Type
Procedure
Intervention Name(s)
taTME
Other Intervention Name(s)
transanal total mesorectal excision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
abdTME
Other Intervention Name(s)
abdominal total mesorectal excision
Intervention Description
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
Primary Outcome Measure Information:
Title
Overall survival
Description
time from surgery to end of follow-up or death
Time Frame
60 months
Title
cancer-specific survival
Description
time from surgery to end of follow-up or death due to rectal cancer
Time Frame
60 months
Title
disease-specific survival
Description
time from surgery to end of follow-up or death due to or recurrence of rectal cancer
Time Frame
60 months
Secondary Outcome Measure Information:
Title
positive resection margin
Description
tumor extending to the resection margin in pathological examination (R0, R1)
Time Frame
30 days
Title
Quirke Score
Description
Quality of mesorectal excision in pathological examination (Good, modest, bad)
Time Frame
30 days
Title
circular resection margin (CRM)
Description
size of circular resection margin (mm) in pathological examination
Time Frame
30 days
Title
number of lymph nodes
Description
number of lymph nodes in pathological examination
Time Frame
30 days
Title
postoperative morbidity
Description
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
Title
postoperative 90-day mortality
Description
Number of patients who die in the first 90 days after surgery
Time Frame
90 days
Title
relapse-free survival
Description
local recurrence
Time Frame
60 months
Title
recurrence-free survival
Description
local or systemic recurrence
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas Marti, Dr. med.
Phone
+41 71 494 13 39
Email
lukas.marti@kssg.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Yanic Ammann
Phone
+41 71 494 93 53
Email
yanic.ammann@kssg.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Marti, Dr. med.
Organizational Affiliation
Leitender Arzt, Chirurige KSSG
Official's Role
Study Director
Facility Information:
Facility Name
Department of surgery, Cantonal hospital of St. Gallen
City
St. Gallen
State/Province
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Marti, M D
Phone
41-71-494-1339
Ext
0041 71
Email
lukas.marti@kssg.ch
First Name & Middle Initial & Last Name & Degree
Lukas Marti, M D
First Name & Middle Initial & Last Name & Degree
Kathrin Müller

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Abdominal or Transanal TME for Rectal Cancer Therapy

We'll reach out to this number within 24 hrs