JOURNAL ONKOLOGIE – STUDIE

Abdominal or Transanal TME for Rectal Cancer Therapy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04969107

Studienbeginn:
Januar 2012

Letztes Update:
08.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms, Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Cantonal Hospital of St. Gallen

Collaborator:
-

Studienleiter

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

Kontakt

Lukas Marti, Dr. med.
Kontakt:
Phone: +41 71 494 13 39
E-Mail: lukas.marti@kssg.ch» Kontaktdaten anzeigen

Yanic Ammann
Kontakt:
Phone: +41 71 494 93 53
E-Mail: yanic.ammann@kssg.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of surgery, Cantonal hospital of St. Gallen
9007 St. Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Lukas Marti, M D
Phone: 41-71-494-1339
Phone (ext.): 0041 71
E-Mail: lukas.marti@kssg.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - 60 months):
time from surgery to end of follow-up or death

2. cancer-specific survival (Time Frame - 60 months):
time from surgery to end of follow-up or death due to rectal cancer

3. disease-specific survival (Time Frame - 60 months):
time from surgery to end of follow-up or death due to or recurrence of rectal cancer

Secondary outcome:

1. positive resection margin (Time Frame - 30 days):
tumor extending to the resection margin in pathological examination (R0, R1)

2. Quirke Score (Time Frame - 30 days):
Quality of mesorectal excision in pathological examination (Good, modest, bad)

3. circular resection margin (CRM) (Time Frame - 30 days):
size of circular resection margin (mm) in pathological examination

4. number of lymph nodes (Time Frame - 30 days):
number of lymph nodes in pathological examination

5. postoperative morbidity (Time Frame - 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 (Time Frame - 90 days):
Number of patients who die in the first 90 days after surgery

7. relapse-free survival (Time Frame - 60 months):
local recurrence

8. recurrence-free survival (Time Frame - 60 months):
local or systemic recurrence

Studien-Arme

Active Comparator: transanal TME (taTME)
patients with rectal cancer receiving transanal TME
Active Comparator: abdominal TME (abTME)
patients with rectal cancer receiving open, laparoscopic or robotic TME

Geprüfte Regime

taTME (transanal total mesorectal excision):
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 (abdominal total mesorectal excision):
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.

Quelle: ClinicalTrials.gov

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