Low Anterior Resection SyndromeNCT04279080
LARS in Ovarian Cancer Patients
An observational study of Low Anterior Resection Syndrome, run by Medical University of Vienna.
Trial summary
Background: Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- low anterior resection syndrome evaluation
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Dec 2018
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen.
Who may be able to join
- low anterior resection because of ovarian or rectal cancer
Who cannot join
- neoadjuvant or adjuvant radiotherapy
About this study
Official title: Low Anterior Resection Syndrome (LARS) in Ovarian Cancer Patients - a Multi-centre Comparative Analysis.
Background:
Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort.
Read more
Methods:
A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS".
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- low anterior resection syndrome evaluation
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low anterior resection syndrome evaluationOther
evaluation of postoperative functional bowel outcome
| Study group | Role | What they receive |
|---|---|---|
| 1 | rectal cancer patients Receives: Other: low anterior resection syndrome evaluation | |
| 2 | ovarian cancer patients Receives: Other: low anterior resection syndrome evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional bowel outcome after low anterior resection
low anterior resection syndrome score, questionnaire via telephone call or personal contact
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jan 2003
- 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 Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Harpain, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279080
- Sponsor's protocol ID
- 1201/2018
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Anterior Resection Syndrome (LARS) in Ovarian Cancer Patients - a Multi-centre Comparative Analysis.
- ClinicalTrials.gov ID
- NCT04279080
- Acronym / sponsor ID
- 1201/2018
- Conditions
- Low Anterior Resection Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Feb 2020 (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.
Background:
Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort.
Methods:
A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS".
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: low anterior resection syndrome evaluationrectal cancer patients |
| 2 | – | Other: low anterior resection syndrome evaluationovarian cancer patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen.
Key inclusion criteria (1 listed)
- low anterior resection because of ovarian or rectal cancer
Key exclusion criteria (1 listed)
- neoadjuvant or adjuvant radiotherapy
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 |
|---|---|---|
| low anterior resection syndrome evaluationevaluation of postoperative functional bowel outcome | Other | 1, 2 |
Primary outcome
functional bowel outcome after low anterior resection
Time frame: 1 year
low anterior resection syndrome score, questionnaire via telephone call or personal contact
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 20 Feb 2020.
Related trials for Low Anterior Resection Syndrome
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Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
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Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
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Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome, run by Medical University of Vienna.
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 1 inclusion and 1 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
functional bowel outcome after low anterior resection (time frame: 1 year). 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 20 Feb 2020.