Cancer, Rectum
Conditions
Keywords
TME (total mesorectal excision), Transanal TME, Laparoscopic TME, Robotic TME, Open TME, Quality of life
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
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.
Interventions
PROCEDURETotal mesorectal excision for rectal cancer
Sponsors
Kantonsspital Winterthur KSW
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life, including functional and symptom scales, incontinence scores, sexual function | 10 years | taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best) |
| Date of surgery | day of surgery | date of surgery (day-month-year) |
| Tumor localisation | 10 years | Description of tumor localisation |
| Comorbidities | day of surgery | Charlson index |
| Perioperative complications | 90 days | Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index) |
| Histological results | 30 days | Histological staging and grading of the specimen by a pathologist |
| Perioperative mortality | 90 days | Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index |
| Age | 10 years | Age (years) |
| Body mass index | 10 years | BM (kg/m2) |
| Gender | 10 years | Sex (male, female) |
| ASA score | 10 years | American Society of Anesthesiologists score (I to V) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery time | day of surgery | Duration of surgery in minutes |
| Length of hospital stay | 90 days | Length of hospital stay in days |
| Readmission rate | 90 days | Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated |
| Costs | 10 years | At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing |
| Perioperative treatment | 10 years | Chemoradiation before or after surgery, other treatments necessary |
Countries
Switzerland
Contacts
Primary ContactMichel Adamina, Prof/MD/MSc
Backup ContactKantonsspital Winterthur
Outcome results
None listed