Rectal CancerNCT06505863
Quality of Life After Transanal Total Mesorectal Excision Compared to Traditional Total Mesorectal Excision
An observational study of Rectal Cancer and Quality of Life, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Quality of Life, Functional Outcome
- What is being tested?
- Transanal total mesorectal excision and Abdominal total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 249 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2024to 1 Jul 2025
- Phase
- Observational
- 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
Study population: Patients receiving elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer at the Cantonal hospital of St.Gallen, Switzerland.
Who may be able to join
- elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer
Who cannot join
- diagnoses other than rectal cancer
- recurrent rectal cancer
- partial mesorectal excision
- discontinuity resection (no anastomosis)
- incomplete TNM staging information
- metastatic cancer
Show all 10Show fewer
- 30-day mortality
- lack of quality of life data
- patient decline
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cantonal Hospital of St.Gallen
Sankt Gallen, Canton of St. Gallen, 9000
About this study
Official title: Does Transanal Total Mesorectal Excision (taTME) Result in Better Quality of Life and Functional Outcomes Than Traditional Total Mesorectal Excision? A Retrospective Propensity Score-adjusted Cohort Study
The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)
Read the detailed description
Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.
- Conditions
- Rectal Cancer, Quality of Life, Functional Outcome, Surgery
- Being tested
- Transanal total mesorectal excision, Abdominal total mesorectal excision
- Keywords
- Transanal total mesorectal excision, Laparoscopic total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal total mesorectal excisionProcedure or surgery
Transanal approach in surgical treatment of rectal cancer along the anatomical and embryological planes, called total mesorectal excision, as described in 1988 by Heald et al.
Abdominal total mesorectal excisionProcedure or surgery
Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III
| Study group | Role | What they receive |
|---|---|---|
| taTME | Patients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III Receives: Procedure: Transanal total mesorectal excision | |
| abTME | Patients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III Receives: Procedure: Abdominal total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL)
Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30):
- Overall QoL
- QLQ-total
Measured: 5 years after initial operation
Secondary outcomes (1)
Functional outcomes
Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30):
- physical functioning
- role functioning
- cognitive functioning
- emotional functioning
- social functioning
- fatigue
- pain
- nausea and vomiting
- appetite loss
- dyspnea
- insomnia
- constipation
- diarrhea
- financial difficulties
Measured: 5 years after initial operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Jan 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanic Ammann, Cantonal Hospital of St. Gallen
- Investigators
- Walter Brunner, PD Dr. med., Study director, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505863
- Sponsor's protocol ID
- taTME QoL
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The anonymized patient data that support the findings of this study are available and can be obtained upon reasonable request.
Publications
Heald RJ. The 'Holy Plane' of rectal surgery. J R Soc Med. 1988 Sep;81(9):503-8. doi: 10.1177/014107688808100904. No abstract available.
PubMed 3184105Ammann Y, Klein M, Marti L, Warschkow R, Strose L, Sparn M, Jager T, Bischofberger S, Brunner W. Does transanal total mesorectal excision (taTME) result in better quality of life and functional outcomes than traditional TME does? A retrospective propensity score-adjusted cohort study. Langenbecks Arch Surg. 2025 Apr 30;410(1):149. doi: 10.1007/s00423-025-03724-6.
PubMed 40304801
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transanal Total Mesorectal Excision (taTME) Result in Better Quality of Life and Functional Outcomes Than Traditional Total Mesorectal Excision? A Retrospective Propensity Score-adjusted Cohort Study
- ClinicalTrials.gov ID
- NCT06505863
- Acronym / sponsor ID
- taTME QoL
- Conditions
- Rectal Cancer, Quality of Life, Functional Outcome, Surgery
- Keywords
- Transanal total mesorectal excision, Laparoscopic total mesorectal excision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 17 Jul 2024 (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.
The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)
Detailed description
Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taTME | – | Procedure: Transanal total mesorectal excisionPatients who underwent transanal total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III |
| abTME | – | Procedure: Abdominal total mesorectal excisionPatients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer at the Cantonal hospital of St.Gallen, Switzerland.
Key inclusion criteria (1 listed)
- elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer
Key exclusion criteria (10 listed)
- diagnoses other than rectal cancer
- recurrent rectal cancer
- partial mesorectal excision
- discontinuity resection (no anastomosis)
- incomplete TNM staging information
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 |
|---|---|---|
| Transanal total mesorectal excisionTransanal approach in surgical treatment of rectal cancer along the anatomical and embryological planes, called total mesorectal excision, as described in 1988 by Heald et al. | Procedure or surgery | taTME |
| Abdominal total mesorectal excisionPatients who underwent laparoscopic, robotic, or open total mesorectal excision with anastomosis for primary rectal cancer UICC stage I to III | Procedure or surgery | abTME |
Primary outcome
Quality of life (QoL)
Time frame: 5 years after initial operation
Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): * Overall QoL * QLQ-total
1 secondary outcome
Functional outcomes
Time frame: 5 years after initial operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 3184105Heald RJ. The 'Holy Plane' of rectal surgery. J R Soc Med. 1988 Sep;81(9):503-8. doi: 10.1177/014107688808100904. No abstract available.
- Derived from this study: PubMed 40304801Ammann Y, Klein M, Marti L, Warschkow R, Strose L, Sparn M, Jager T, Bischofberger S, Brunner W. Does transanal total mesorectal excision (taTME) result in better quality of life and functional outcomes than traditional TME does? A retrospective propensity score-adjusted cohort study. Langenbecks Arch Surg. 2025 Apr 30;410(1):149. doi: 10.1007/s00423-025-03724-6.
- Individual participant dataSharing planned: No. The anonymized patient data that support the findings of this study are available and can be obtained upon reasonable request.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Walter Brunner, PD Dr. med. study director
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Quality of Life, 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 10 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: finished, as of the sponsor's last update on 14 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) (time frame: 5 years after initial operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505863, which also lists 2 linked publications.
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 14 Jul 2025.