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Recruiting NCT05112016

Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

Observational Rectum Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total mesorectal excision for rectal cancer.
Who it may be relevant to
Registry conditions: Rectum, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Total mesorectal excision for rectal cancer

Primary outcome measures

  • Perioperative mortality [Time frame: 90 days]
  • Age [Time frame: 10 years]
  • Body mass index [Time frame: 10 years]
  • Gender [Time frame: 10 years]
  • ASA score [Time frame: 10 years]
  • Date of surgery [Time frame: day of surgery]
  • Tumor localisation [Time frame: 10 years]
  • Comorbidities [Time frame: day of surgery]
  • Perioperative complications [Time frame: 90 days]
  • Histological results [Time frame: 30 days]
Secondary outcome measures (5)
  • Perioperative treatment [Time frame: 10 years]
  • Surgery time [Time frame: day of surgery]
  • Length of hospital stay [Time frame: 90 days]
  • Readmission rate [Time frame: 90 days]
  • Costs [Time frame: 10 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Kantonsspital Winterthur — Winterthur

Identifiers

NCT: NCT05112016 · TME-KSW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗