Cancer Clinical Trial
— TME-KSWOfficial title:
Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
NCT number | NCT05112016 |
Other study ID # | TME-KSW |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2007 |
Est. completion date | July 31, 2028 |
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
Status | Recruiting |
Enrollment | 250 |
Est. completion date | July 31, 2028 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Age < 18 - No informed consent (no general consent, no consent to use personal data for research purpose) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Winterthur | Winterthur | Zürich |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Winterthur KSW |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative mortality | Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index | 90 days | |
Primary | Age | Age (years) | 10 years | |
Primary | Body mass index | BM (kg/m2) | 10 years | |
Primary | Gender | Sex (male, female) | 10 years | |
Primary | ASA score | American Society of Anesthesiologists score (I to V) | 10 years | |
Primary | Date of surgery | date of surgery (day-month-year) | day of surgery | |
Primary | Tumor localisation | Description of tumor localisation | 10 years | |
Primary | Comorbidities | Charlson index | day of surgery | |
Primary | Perioperative complications | Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index) | 90 days | |
Primary | Histological results | Histological staging and grading of the specimen by a pathologist | 30 days | |
Primary | 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 | Perioperative treatment | Chemoradiation before or after surgery, other treatments necessary | 10 years | |
Secondary | Surgery time | Duration of surgery in minutes | day of surgery | |
Secondary | Length of hospital stay | Length of hospital stay in days | 90 days | |
Secondary | Readmission rate | Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated | 90 days | |
Secondary | Costs | At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing | 10 years |
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