SurvivalNCT04969107
Abdominal or Transanal TME for Rectal Cancer Therapy
A study testing taTME and abdTME in people with Survival and Postoperative Morbidity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survival, Postoperative Morbidity, Mortality
- What is being tested?
- taTME and abdTME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2012to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients receiving elective total mesorectal excision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of surgery, Cantonal hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Lukas Marti, M D, 41-71-494-1339 ext. 0041 71, lukas.marti@kssg.ch
Lukas Marti, M D
About this study
Official title: Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Survival, Postoperative Morbidity, Mortality, Recurrence
- Being tested
- taTME, abdTME
- Keywords
- TME, Rectal Cancer, transanal, local recurrence
- Medical subject headings
- Recurrence, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taTMEProcedure or surgery
Also called 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.
abdTMEProcedure or surgery
Also called abdominal total mesorectal excision
Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
| Study group | Role | What they receive |
|---|---|---|
| transanal TME (taTME) | Active comparator | patients with rectal cancer receiving transanal TME Receives: Procedure: taTME |
| abdominal TME (abTME) | Active comparator | patients with rectal cancer receiving open, laparoscopic or robotic TME Receives: Procedure: abdTME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
time from surgery to end of follow-up or death
Measured: 60 months
cancer-specific survival
time from surgery to end of follow-up or death due to rectal cancer
Measured: 60 months
disease-specific survival
time from surgery to end of follow-up or death due to or recurrence of rectal cancer
Measured: 60 months
Secondary outcomes (8)
positive resection margin
tumor extending to the resection margin in pathological examination (R0, R1)
Measured: 30 days
Quirke Score
Quality of mesorectal excision in pathological examination (Good, modest, bad)
Measured: 30 days
circular resection margin (CRM)
size of circular resection margin (mm) in pathological examination
Measured: 30 days
number of lymph nodes
number of lymph nodes in pathological examination
Measured: 30 days
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
Measured: 30 days
postoperative 90-day mortality
Number of patients who die in the first 90 days after surgery
Measured: 90 days
relapse-free survival
local recurrence
Measured: 60 months
recurrence-free survival
local or systemic recurrence
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Marti, Cantonal Hospital of St. Gallen
- Investigators
- Lukas Marti, Dr. med., Study director, Leitender Arzt, Chirurige KSSG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969107
- Sponsor's protocol ID
- TMEabdVSta
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04969107
- Acronym / sponsor ID
- TMEabdVSta
- Conditions
- Survival, Postoperative Morbidity, Mortality, Recurrence
- Keywords
- TME, Rectal Cancer, transanal, local recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal TME (taTME) | Active comparator | Procedure: taTMEpatients with rectal cancer receiving transanal TME |
| abdominal TME (abTME) | Active comparator | Procedure: abdTMEpatients with rectal cancer receiving open, laparoscopic or robotic TME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients receiving elective total mesorectal excision
Key exclusion criteria (8 listed)
- diagnosis other than rectal cancer
- partial mesorectal excision
- discontinuity resection (no anastomosis)
- incomplete Staging
- metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taTMEAlso: transanal total mesorectal excisionResection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach. | Procedure or surgery | transanal TME (taTME) |
| abdTMEAlso: abdominal total mesorectal excisionResection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach. | Procedure or surgery | abdominal TME (abTME) |
Primary outcome
Overall survival
Time frame: 60 months
time from surgery to end of follow-up or death
cancer-specific survival
Time frame: 60 months
time from surgery to end of follow-up or death due to rectal cancer
disease-specific survival
Time frame: 60 months
time from surgery to end of follow-up or death due to or recurrence of rectal cancer
8 secondary outcomes
positive resection margin
Time frame: 30 days
Quirke Score
Time frame: 30 days
circular resection margin (CRM)
Time frame: 30 days
number of lymph nodes
Time frame: 30 days
postoperative morbidity
Time frame: 30 days
postoperative 90-day mortality
Time frame: 90 days
relapse-free survival
Time frame: 60 months
recurrence-free survival
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Marti, Dr. med. study director
Leitender Arzt, Chirurige KSSG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taTME and abdTME in people with Survival and Postoperative Morbidity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukas Marti, Dr. med. (+41 71 494 13 39, lukas.marti@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.