Abdominal or Transanal TME for Rectal Cancer Therapy

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969107
• Other study ID #: TMEabdVSta
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: Lukas Marti, Dr. med.
• Phone: +41 71 494 13 39
• Email: lukas.marti[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mortality
• Postoperative Morbidity
• Rectal Neoplasms
• Recurrence
• Survival

Intervention

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.
• abdTME
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.

Locations

Country	Name	City	State
Switzerland	Department of surgery, Cantonal hospital of St. Gallen	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time from surgery to end of follow-up or death	60 months
Primary	cancer-specific survival	time from surgery to end of follow-up or death due to rectal cancer	60 months
Primary	disease-specific survival	time from surgery to end of follow-up or death due to or recurrence of rectal cancer	60 months
Secondary	positive resection margin	tumor extending to the resection margin in pathological examination (R0, R1)	30 days
Secondary	Quirke Score	Quality of mesorectal excision in pathological examination (Good, modest, bad)	30 days
Secondary	circular resection margin (CRM)	size of circular resection margin (mm) in pathological examination	30 days
Secondary	number of lymph nodes	number of lymph nodes in pathological examination	30 days
Secondary	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
Secondary	postoperative 90-day mortality	Number of patients who die in the first 90 days after surgery	90 days
Secondary	relapse-free survival	local recurrence	60 months
Secondary	recurrence-free survival	local or systemic recurrence	60 months