Low Anterior Resection SyndromePrePostLARSNCT04040842
International Low Anterior Resection Score Evaluation
An observational study of Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial summary
Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score. Primary outcome measure: LARS score before surgery and 1 year after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Patients undergoing low anterior resection
- How many people
- 400 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2019to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
Who may be able to join
- Patients undergoing rectal cancer surgery on curative intent.
- Elective surgery patients.
- Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included.
- Patients aged 18 years and over should be included.
Who cannot join
- Patients undergoing a procedure purely for diagnosis or staging should be excluded.
- Patients with palliative treatment.
- Patients with recurrence should be excluded.
- Patients with dementia
- Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc
Trial locations and contacts
1 site in 1 country.
Povilas Kavaliauskas, MD contact
Lithuania1 site, 1 recruiting
- Recruiting
National Cancer Institute
Vilnius, 08406
Audrius Dulskas, MD, PhD, 852786812, audrius.dulskas@gmail.com
Povilas Kavaliauskas
About this study
Official title: Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
- Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
- Primary outcome measure: LARS score before surgery and 1 year after the surgery.
- Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.
Read the detailed description
All patients undergoing treatment for rectal rectal will be included in the study. Before any treatment all the included patients will be asked to fill the LARS score (5 question questionnaire with differently weighted answers for assessing the low anterior resection score). One year after the low anterior resection (without the stoma) or following the stoma take down patients will be reassessed. The LARS score will be filled one again. Patient characteristics, age, cancer stage, level of anastomosis will be assessed aswel.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Patients undergoing low anterior resection
- Keywords
- Rectal cancer, low anterior resection, low anterior resection syndrome
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing low anterior resectionDiagnostic test
Patients before the surgery and one year after the surgery will be assessed with questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score change comparing before surgery and 1 year after the surgery.
Low anterior resection score is a simple questionnaire consisting of five simple questions for bowel function assessment after anterior resection. The maximum number is between 0 and 42. No LARS (good bowel function) is from 0 to 20; minor LARS - 21-29 and major LARS (poor bowel function) more than 29.
Between average LARS score before and after curative surgery and also comparing these with published LARS score on normal population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Audrius Dulskas, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Investigators
- Joseph Nunoo-Mensah, MD, Study director, King's College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040842
- Sponsor's protocol ID
- ISUCRS
- Acronym
- PrePostLARS
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2019
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
- ClinicalTrials.gov ID
- NCT04040842
- Acronym / sponsor ID
- PrePostLARS / ISUCRS
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Rectal cancer, low anterior resection, low anterior resection syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- King's College London, National Cancer Institute (NCI)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Aug 2019 (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.
- Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
- Primary outcome measure: LARS score before surgery and 1 year after the surgery.
- Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.
Detailed description
All patients undergoing treatment for rectal rectal will be included in the study. Before any treatment all the included patients will be asked to fill the LARS score (5 question questionnaire with differently weighted answers for assessing the low anterior resection score). One year after the low anterior resection (without the stoma) or following the stoma take down patients will be reassessed. The LARS score will be filled one again. Patient characteristics, age, cancer stage, level of anastomosis will be assessed aswel.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
Key inclusion criteria (4 listed)
- Patients undergoing rectal cancer surgery on curative intent.
- Elective surgery patients.
- Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included.
- Patients aged 18 years and over should be included.
Key exclusion criteria (5 listed)
- Patients undergoing a procedure purely for diagnosis or staging should be excluded.
- Patients with palliative treatment.
- Patients with recurrence should be excluded.
- Patients with dementia
- Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc
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 |
|---|---|---|
| Patients undergoing low anterior resectionPatients before the surgery and one year after the surgery will be assessed with questionnaire. | Diagnostic test | – |
Primary outcome
LARS score change comparing before surgery and 1 year after the surgery.
Time frame: 12 months
Low anterior resection score is a simple questionnaire consisting of five simple questions for bowel function assessment after anterior resection. The maximum number is between 0 and 42. No LARS (good bowel function) is from 0 to 20; minor LARS - 21-29 and major LARS (poor bowel function) more than 29. Between average LARS score before and after curative surgery and also comparing these with published LARS score on normal population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
Povilas Kavaliauskas, MD contact
Joseph Nunoo-Mensah, MD study director
King's College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Nov 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrius Dulskas, MD, PhD (867520094, audrius.dulskas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS score change comparing before surgery and 1 year after the surgery. (time frame: 12 months). 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 9 Nov 2023.