An observational study in Rectum and Cancer, sponsored by Kantonsspital Winterthur KSW. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Kantonsspital Winterthur KSW · Observational
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
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 250 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with rectal cancer who benefit from surgical resection
Exclusion Criteria:
Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)
Procedure: Total mesorectal excision for rectal cancer
Also known as: TME
Perioperative mortality
Reporting perioperative mortality with Clavien-Dindo \& Comprehensive Complications Index
Time frame: 90 days
Age
Age (years)
Time frame: 10 years
Body mass index
BM (kg/m2)
Time frame: 10 years
Gender
Sex (male, female)
Time frame: 10 years
ASA score
American Society of Anesthesiologists score (I to V)
Time frame: 10 years
Date of surgery
date of surgery (day-month-year)
Time frame: day of surgery
Tumor localisation
Description of tumor localisation
Time frame: 10 years
Comorbidities
Charlson index
Time frame: day of surgery
Perioperative complications
Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)
Time frame: 90 days
Histological results
Histological staging and grading of the specimen by a pathologist
Time frame: 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)
Time frame: 10 years
Perioperative treatment
Chemoradiation before or after surgery, other treatments necessary
Time frame: 10 years
Surgery time
Duration of surgery in minutes
Time frame: day of surgery
Length of hospital stay
Length of hospital stay in days
Time frame: 90 days
Readmission rate
Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated
Time frame: 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
Time frame: 10 years
Plan to share: Undecided
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Kantonsspital Winterthur KSW