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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Rectum
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Michel Adamina, Prof/MD/MSc; Phone Number: +41522663376; Email: michel.adamina@ksw.ch

Study Locations

• Switzerland
  • Zürich
    • Winterthur, Zürich, Switzerland, 8401
      • Recruiting
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with rectal cancer who benefit from surgical resection

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative mortality	Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index	90 days
Age	Age (years)	10 years
Body mass index	BM (kg/m2)	10 years
Gender	Sex (male, female)	10 years
ASA score	American Society of Anesthesiologists score (I to V)	10 years
Date of surgery	date of surgery (day-month-year)	day of surgery
Tumor localisation	Description of tumor localisation	10 years
Comorbidities	Charlson index	day of surgery
Perioperative complications	Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)	90 days
Histological results	Histological staging and grading of the specimen by a pathologist	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)	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative treatment	Chemoradiation before or after surgery, other treatments necessary	10 years
Surgery time	Duration of surgery in minutes	day of surgery
Length of hospital stay	Length of hospital stay in days	90 days
Readmission rate	Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated	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	10 years

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2007
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): July 31, 2028

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (ACTUAL): November 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; TME (total mesorectal excision); Transanal TME; Laparoscopic TME; Robotic TME; Open TME
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: TME-KSW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No