TME-KSW: Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Sponsor

Kantonsspital Winterthur KSW (Other)

Overall Status

Recruiting

CT.gov ID

NCT05112016

Collaborator

(none)

250

Enrollment

Location

259

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rectum Cancer	Procedure: Total 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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Actual Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jul 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
TME for rectal cancer Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)	Procedure: Total mesorectal excision for rectal cancer Other Names: TME

Arm

Intervention/Treatment

TME for rectal cancer

Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)

Procedure: Total mesorectal excision for rectal cancer

Other Names:

TME

Outcome Measures

Primary Outcome Measures

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)
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
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)

Secondary Outcome Measures

Perioperative treatment [10 years]
Chemoradiation before or after surgery, other treatments necessary
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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