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)
300
1
2
120
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
  • 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2021