RectumTME-KSWNCT05112016
Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
An observational study of Rectum and Cancer, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Total mesorectal excision for rectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2007to 31 Jul 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with rectal cancer who benefit from surgical resection
Who may be able to join
- Men and Women >18 years
- Patients with rectal cancer
- Underwent mesorectal excision
- Agreed to fill in a validated questionnaires before surgery and after stoma reversal
- Informed consent
Who cannot join
- Age < 18
- No informed consent (no general consent, no consent to use personal data for research purpose)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kantonsspital Winterthur contact
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Michel Adamina, Prof/MD/MSc, +41522663634, michel.adamina@ksw.ch
About this study
The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer
Read the detailed description
Outcomes of mesorectal excision patients will be analysed. Medical records will be reviewed and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of life data. A retrospective cohort over 10 years (2007-2016) will serve as a control to a prospective cohort over 10 further years (2017-2026) as to investigate trends in perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size). Prospective data on bowel function, urogenital function and quality of life will measured at time of diagnosis and further. Variations in neoadjuvant/adjuvant treatment and surgical approaches will be assessed for their effect on the outcomes of interest.
- Being tested
- Total mesorectal excision for rectal cancer
- Keywords
- TME (total mesorectal excision), Transanal TME, Laparoscopic TME, Robotic TME, Open TME, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total mesorectal excision for rectal cancerProcedure or surgery
Also called TME
| Study group | Role | What they receive |
|---|---|---|
| TME for rectal cancer | Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME) Receives: Procedure: Total mesorectal excision for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative mortality
Reporting perioperative mortality with Clavien-Dindo \& Comprehensive Complications Index
Measured: 90 days
Age
Age (years)
Measured: 10 years
Body mass index
BM (kg/m2)
Measured: 10 years
Gender
Sex (male, female)
Measured: 10 years
ASA score
American Society of Anesthesiologists score (I to V)
Measured: 10 years
Date of surgery
date of surgery (day-month-year)
Measured: day of surgery
Tumor localisation
Description of tumor localisation
Measured: 10 years
Comorbidities
Charlson index
Measured: day of surgery
Perioperative complications
Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)
Measured: 90 days
Histological results
Histological staging and grading of the specimen by a pathologist
Measured: 30 days
Quality of life, including functional and symptom scales, incontinence scores, sexual function
taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best)
Measured: 10 years
Secondary outcomes (5)
Perioperative treatment
Chemoradiation before or after surgery, other treatments necessary
Measured: 10 years
Surgery time
Duration of surgery in minutes
Measured: day of surgery
Length of hospital stay
Length of hospital stay in days
Measured: 90 days
Readmission rate
Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated
Measured: 90 days
Costs
At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2007
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectumStudies 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
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Adamina, Prof/MD/MSc, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112016
- Sponsor's protocol ID
- TME-KSW
- Acronym
- TME-KSW
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
- ClinicalTrials.gov ID
- NCT05112016
- Acronym / sponsor ID
- TME-KSW / TME-KSW
- Keywords
- TME (total mesorectal excision), Transanal TME, Laparoscopic TME, Robotic TME, Open TME, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Nov 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.
The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer
Detailed description
Outcomes of mesorectal excision patients will be analysed. Medical records will be reviewed and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of life data. A retrospective cohort over 10 years (2007-2016) will serve as a control to a prospective cohort over 10 further years (2017-2026) as to investigate trends in perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size). Prospective data on bowel function, urogenital function and quality of life will measured at time of diagnosis and further. Variations in neoadjuvant/adjuvant treatment and surgical approaches will be assessed for their effect on the outcomes of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TME for rectal cancer | – | Procedure: Total mesorectal excision for rectal cancerPatients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rectal cancer who benefit from surgical resection
Key inclusion criteria (5 listed)
- Men and Women >18 years
- Patients with rectal cancer
- Underwent mesorectal excision
- Agreed to fill in a validated questionnaires before surgery and after stoma reversal
- Informed consent
Key exclusion criteria (2 listed)
- Age < 18
- No informed consent (no general consent, no consent to use personal data for research purpose)
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 |
|---|---|---|
| Total mesorectal excision for rectal cancerAlso: TME | Procedure or surgery | TME for rectal cancer |
Primary outcome
Perioperative mortality
Time frame: 90 days
Reporting perioperative mortality with Clavien-Dindo \& Comprehensive Complications Index
Age
Time frame: 10 years
Age (years)
Body mass index
Time frame: 10 years
BM (kg/m2)
Gender
Time frame: 10 years
Sex (male, female)
ASA score
Time frame: 10 years
American Society of Anesthesiologists score (I to V)
Date of surgery
Time frame: day of surgery
date of surgery (day-month-year)
Tumor localisation
Time frame: 10 years
Description of tumor localisation
Comorbidities
Time frame: day of surgery
Charlson index
Perioperative complications
Time frame: 90 days
Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)
Histological results
Time frame: 30 days
Histological staging and grading of the specimen by a pathologist
Quality of life, including functional and symptom scales, incontinence scores, sexual function
Time frame: 10 years
taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best)
5 secondary outcomes
Perioperative treatment
Time frame: 10 years
Surgery time
Time frame: day of surgery
Length of hospital stay
Time frame: 90 days
Readmission rate
Time frame: 90 days
Costs
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Kantonsspital Winterthur contact
Michel Adamina, Prof/MD/MSc principal investigator
Kantonsspital Winterthur KSW
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 Rectum and Cancer, run by Kantonsspital Winterthur KSW 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Nov 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel Adamina, Prof/MD/MSc (+41522663376, michel.adamina@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative mortality (time frame: 90 days). The study lists 11 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 Nov 2021.