Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Cancer Clinical Trial

— TME-KSW  

Official title:

Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112016
• Other study ID #: TME-KSW
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Cancer
• Rectal Neoplasms
• Rectum

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