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NCT Number: NCT05112016

Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

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

Recruiting

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Key information

Conditions

RECTUM Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location status: Recruiting

Location contact

Michel Adamina, Prof/MD/MSc

CONTACT

[email protected]

+41522663634

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Total mesorectal excision for rectal cancer

Procedure

Other names: TME

Primary outcomes

  1. Perioperative mortality

    Time frame: 90 days

    Reporting perioperative mortality with Clavien-Dindo & Comprehensive Complications Index

  2. Age

    Time frame: 10 years

    Age (years)

  3. Body mass index

    Time frame: 10 years

    BM (kg/m2)

  4. Gender

    Time frame: 10 years

    Sex (male, female)

  5. ASA score

    Time frame: 10 years

    American Society of Anesthesiologists score (I to V)

  6. Date of surgery

    Time frame: day of surgery

    date of surgery (day-month-year)

  7. Tumor localisation

    Time frame: 10 years

    Description of tumor localisation

  8. Comorbidities

    Time frame: day of surgery

    Charlson index

  9. Perioperative complications

    Time frame: 90 days

    Reporting and grading of postoperative surgical complications (according to Dindo-Clavien classification and/or comprehensive complications index)

  10. Histological results

    Time frame: 30 days

    Histological staging and grading of the specimen by a pathologist

  11. Quality of life, including functional and symptom scales, incontinence scores, sexual function

    Time frame: 10 years

    taTME survey (validated english, german, french versions); from 0 (worst) to 100 (best)

Secondary outcomes

  1. Perioperative treatment

    Time frame: 10 years

    Chemoradiation before or after surgery, other treatments necessary

  2. Surgery time

    Time frame: day of surgery

    Duration of surgery in minutes

  3. Length of hospital stay

    Time frame: 90 days

    Length of hospital stay in days

  4. Readmission rate

    Time frame: 90 days

    Number of patients readmitted within 90 days of index surgery divided by the total number of patients operated

  5. Costs

    Time frame: 10 years

    At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs. Actual costs and micro-costing

Study contacts

Contact information is provided by the study sponsor or research team.

Kantonsspital Winterthur

CONTACT

Michel Adamina, Prof/MD/MSc

CONTACT

[email protected]

+41522663376

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Registry information

Acronym: TME-KSW

Important dates

Study start
2007
Primary completion
2026
Study completion
2028
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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