Rectal CancerNCT06059170
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
A study testing LARS score/ EORTC QLQ C30 in people with Rectal Cancer and Low Anterior Resection Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome
- What is being tested?
- LARS score/ EORTC QLQ C30
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low anterior resection for rectal cancer between 2006-2016
- Adults
Who cannot join
- abdomino perineal resection
- patients who do not understand Dutch
Trial locations and contacts
1 site in 1 country.
About this study
Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS
Read the 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
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Being tested
- LARS score/ EORTC QLQ C30
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARS score/ EORTC QLQ C30Behavioural
administering questionnaire
| Study group | Role | What they receive |
|---|---|---|
| QOL, risk factor and therapeutic options | Other | questionnaires Receives: Behavioral: LARS score/ EORTC QLQ C30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment QoL
Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30)
Measured: up to 10 years after rectal resection
frequencies of therapeutic options to manage LARS
Self developed questionaire to determine what therapeutic options were used to manage LARS
Measured: up to 10 years after rectal resection
Frequency of LARS
Assessment of LARS using validated LARS Score
Measured: up to 10 years after rectal resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cross sectional study
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIHeelkunde, University Hospital, Ghent
- Investigators
- Piet pattyn, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059170
- Sponsor's protocol ID
- 2017/0180
- Status last verified
- Sep 2023
- First submitted
- 2 May 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data are anonymous. only the treating physician has access to the details of the eligible patients
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
- ClinicalTrials.gov ID
- NCT06059170
- Acronym / sponsor ID
- 2017/0180
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cross sectional study
| Arm | Type | Receives |
|---|---|---|
| QOL, risk factor and therapeutic options | Other | Behavioral: LARS score/ EORTC QLQ C30questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low anterior resection for rectal cancer between 2006-2016
- Adults
Key exclusion criteria (2 listed)
- abdomino perineal resection
- patients who do not understand Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LARS score/ EORTC QLQ C30administering questionnaire | Behavioural | QOL, risk factor and therapeutic options |
Primary outcome
Assessment QoL
Time frame: up to 10 years after rectal resection
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
Time frame: up to 10 years after rectal resection
Self developed questionaire to determine what therapeutic options were used to manage LARS
Frequency of LARS
Time frame: up to 10 years after rectal resection
Assessment of LARS using validated LARS Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. all data are anonymous. only the treating physician has access to the details of the eligible patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piet pattyn, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARS score/ EORTC QLQ C30 in people with Rectal Cancer and Low Anterior Resection Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment QoL (time frame: up to 10 years after rectal resection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.