Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Recruiting

• Conditions: Rectum; Cancer
• Interventions: Procedure: Total mesorectal excision for rectal cancer

• Registration Number: NCT05112016
• Lead Sponsor: Kantonsspital Winterthur KSW

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

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 Timeline

• Study Start: 2007-01-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2026-12-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TME for rectal cancer	Total mesorectal excision for rectal cancer	Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)

Primary Outcome Measures

Name	Time	Method
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)
Comorbidities	day of surgery	Charlson index
Perioperative mortality	90 days	Reporting perioperative mortality with Clavien-Dindo \& Comprehensive Complications Index
Date of surgery	day of surgery	date of surgery (day-month-year)
Tumor localisation	10 years	Description of tumor localisation
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zürich, Switzerland