Back to resultsRectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
Primary Purpose
Rectal Cancer, Low Anterior Resection Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
LARS score/ EORTC QLQ C30
Sponsored by
About this trial
This is an interventional supportive care trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria: low anterior resection for rectal cancer between 2006-2016 Adults Exclusion Criteria: abdomino perineal resection patients who do not understand Dutch
Sites / Locations
- University hospital Ghent
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
QOL, risk factor and therapeutic options
Arm Description
questionnaires
Outcomes
Primary Outcome Measures
Assessment QoL
Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30)
frequencies of therapeutic options to manage LARS
Self developed questionaire to determine what therapeutic options were used to manage LARS
Frequency of LARS
Assessment of LARS using validated LARS Score
Secondary Outcome Measures
Full Information
NCT ID
NCT06059170
First Posted
May 2, 2019
Last Updated
September 22, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT06059170
Brief Title
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
Official Title
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Low Anterior Resection Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cross sectional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QOL, risk factor and therapeutic options
Arm Type
Other
Arm Description
questionnaires
Intervention Type
Behavioral
Intervention Name(s)
LARS score/ EORTC QLQ C30
Intervention Description
administering questionnaire
Primary Outcome Measure Information:
Title
Assessment QoL
Description
Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30)
Time Frame
up to 10 years after rectal resection
Title
frequencies of therapeutic options to manage LARS
Description
Self developed questionaire to determine what therapeutic options were used to manage LARS
Time Frame
up to 10 years after rectal resection
Title
Frequency of LARS
Description
Assessment of LARS using validated LARS Score
Time Frame
up to 10 years after rectal resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
low anterior resection for rectal cancer between 2006-2016
Adults
Exclusion Criteria:
abdomino perineal resection
patients who do not understand Dutch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet pattyn, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Ghent
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
all data are anonymous. only the treating physician has access to the details of the eligible patients
Learn more about this trial
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
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