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Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

NCT ID: NCT05112016

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2028-07-31

Brief Summary

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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

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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.

Conditions

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Rectum Cancer

Keywords

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TME (total mesorectal excision) Transanal TME Laparoscopic TME Robotic TME Open TME Quality of life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TME for rectal cancer

Patients with rectal cancer treated by TME (laparoscopic TME, transanal TME, robotic TME, open TME)

Total mesorectal excision for rectal cancer

Intervention Type PROCEDURE

Interventions

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Total mesorectal excision for rectal cancer

Intervention Type PROCEDURE

Other Intervention Names

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TME

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Adamina, Prof/MD/MSc

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Winterthur KSW

Locations

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Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Michel Adamina, Prof/MD/MSc

Role: CONTACT

Phone: +41522663376

Email: [email protected]

Kantonsspital Winterthur

Role: CONTACT

Facility Contacts

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Michel Adamina, Prof/MD/MSc

Role: primary

Other Identifiers

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TME-KSW

Identifier Type: -

Identifier Source: org_study_id