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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06059170
Other study ID # 2017/0180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2017
Est. completion date December 31, 2018

Study information

Verified date September 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS


Description:

Quality of life and risk factors for developing major LARS are explored using the EORTC QLQ C30. Therapeutic options were explored in the cohort experiencing major LARS


Recruitment information / eligibility

Status Completed
Enrollment 187
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - low anterior resection for rectal cancer between 2006-2016 - Adults Exclusion Criteria: - abdomino perineal resection - patients who do not understand Dutch

Study Design


Intervention

Behavioral:
LARS score/ EORTC QLQ C30
administering questionnaire

Locations

Country Name City State
Belgium University hospital Ghent Ghent Oost-Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment QoL Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30) up to 10 years after rectal resection
Primary frequencies of therapeutic options to manage LARS Self developed questionaire to determine what therapeutic options were used to manage LARS up to 10 years after rectal resection
Primary Frequency of LARS Assessment of LARS using validated LARS Score up to 10 years after rectal resection
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