Abdominal or Transanal TME for Rectal Cancer Therapy

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04969107
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Survival; Postoperative Morbidity; Mortality; Recurrence	Procedure: taTME; Procedure: abdTME	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall survival [60 months]

   time from surgery to end of follow-up or death

2. cancer-specific survival [60 months]

   time from surgery to end of follow-up or death due to rectal cancer

3. disease-specific survival [60 months]

   time from surgery to end of follow-up or death due to or recurrence of rectal cancer

Secondary Outcome Measures

1. positive resection margin [30 days]

   tumor extending to the resection margin in pathological examination (R0, R1)

2. Quirke Score [30 days]

   Quality of mesorectal excision in pathological examination (Good, modest, bad)

3. circular resection margin (CRM) [30 days]

   size of circular resection margin (mm) in pathological examination

4. number of lymph nodes [30 days]

   number of lymph nodes in pathological examination

5. 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

6. postoperative 90-day mortality [90 days]

   Number of patients who die in the first 90 days after surgery

7. relapse-free survival [60 months]

   local recurrence

8. recurrence-free survival [60 months]

   local or systemic recurrence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of surgery, Cantonal hospital of St. Gallen	St. Gallen	Saint Gallen	Switzerland	9007

Sponsors and Collaborators

• Cantonal Hospital of St. Gallen

Investigators

• Study Director: Lukas Marti, Dr. med., Leitender Arzt, Chirurige KSSG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lukas Marti, Dr. med. Lukas Marti, Leitender Arzt Chirurgie, Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT04969107
• Other Study ID Numbers: TMEabdVSta
• First Posted: Jul 20, 2021
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Lukas Marti, Dr. med. Lukas Marti, Leitender Arzt Chirurgie, Cantonal Hospital of St. Gallen: TME; Rectal Cancer; transanal; local recurrence
• Additional relevant MeSH terms: Rectal Neoplasms; Recurrence

Study Results

No Results Posted as of Jul 20, 2021