Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
TME-KSW
1 other identifier
observational
250
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 6, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
November 8, 2021
September 1, 2021
20 years
September 6, 2021
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Perioperative mortality
Reporting perioperative mortality with Clavien-Dindo \& Comprehensive Complications Index
90 days
Age
Age (years)
10 years
Body mass index
BM (kg/m2)
10 years
Gender
Sex (male, female)
10 years
ASA score
American Society of Anesthesiologists score (I to V)
10 years
Date of surgery
date of surgery (day-month-year)
day of surgery
Tumor localisation
Description of tumor localisation
10 years
Comorbidities
Charlson index
day of surgery
Perioperative complications
Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)
90 days
Histological results
Histological staging and grading of the specimen by a pathologist
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)
10 years
Secondary Outcomes (5)
Perioperative treatment
10 years
Surgery time
day of surgery
Length of hospital stay
90 days
Readmission rate
90 days
Costs
10 years
Study Arms (1)
TME for rectal cancer
Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)
Interventions
Eligibility Criteria
Patients with rectal cancer who benefit from surgical resection
You may qualify if:
- 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
You may not qualify if:
- Age \< 18
- No informed consent (no general consent, no consent to use personal data for research purpose)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Adamina, Prof/MD/MSc
Kantonsspital Winterthur KSW
Central Study Contacts
Kantonsspital Winterthur
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2021
First Posted
November 8, 2021
Study Start
January 1, 2007
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
July 31, 2028
Last Updated
November 8, 2021
Record last verified: 2021-09