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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date September 2021
Source Kantonsspital Winterthur KSW
Contact Michel Adamina, Prof/MD/MSc
Phone +41522663376
Email michel.adamina@ksw.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total mesorectal excision for rectal cancer


Locations

Country Name City State
Switzerland Kantonsspital Winterthur Winterthur Zürich

Sponsors (1)

Lead Sponsor Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

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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