LARS - Low Anterior Resection SyndromeNCT05289531
(LARS) Score Validation of Turkish Language
An observational study of LARS - Low Anterior Resection Syndrome, run by Ankara University.
Trial summary
Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to measure this syndrome and its impact on quality of life in Danish patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LARS - Low Anterior Resection Syndrome
- What is being tested?
- Rectal Resection Patients
- Type of treatment
- Surgery or procedure
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 28 Feb 2020
- How long will I take part?
- 4 Years
- 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
- Adult, Older adult
Study population: All patients had their surgeries performed by expert colorectal surgeons with at least 15 years of experience and performing more than 20 rectal cancer surgeries in a year to minimize surgeon-related hazards for poor functional outcome. The first rectal resection with a diverting ileostomy in the study group was performed in May 2000, which was closed in January 2001, and the last stoma closure was in September 2018. All patients had their bowel continuity restored for at least 6 months prior to completing the survey.
Who may be able to join
- rectal adenocarcinoma within 15 cm from the anal verge
- LAR with either PME or TME.
- Bowel continuity restored for at least 18 months when invited for the study.
Who cannot join
- failed R0 surgery,
- recurrence or dissemination,
- having intestinal stoma,
- previous cancer (except minor skin cancers)
- dementia and inability to speak Turkish (i.e., the need for a translator during treatment).
About this study
Official title: Validation of the Turkish Translation of the Low Anterior Resection Syndrome (LARS) Score
Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to measure this syndrome and its impact on quality of life in Danish patients. Recently, English and many other language versions have been validated. The aim of this study was to validate the Turkish translation of the LARS score in Turkish patients who have undergone treatment for rectal cancer.
Read the detailed description
A total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses. The association between the LARS score and quality of life and the test-retest reliability were studied. The intraclass correlation coefficient (ICC) was calculated to understand the degree of reliability.
- Conditions
- LARS - Low Anterior Resection Syndrome
- Being tested
- Rectal Resection Patients
- Keywords
- Turkish LARS
- 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.
Rectal Resection PatientsProcedure or surgery
Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery
| Study group | Role | What they receive |
|---|---|---|
| Rectal resection patients | Four Turkish centers participated in data collection in 2016. The inclusion criteria were rectal adenocarcinoma within 15 cm from the anal verge and LAR with either PME or TME. All patients had bowel continuity restored for at least 18 months when invited for the study. Exclusion criteria included failed R0 surgery, recurrence or dissemination, having intestinal stoma, previous cancer (except minor skin cancers) dementia and inability to speak Turkish (i.e., the need for a translator during treatment). A research assistant at each center identified the consecutive series of eligible patients for each participating consultant surgeon Receives: Procedure: Rectal Resection Patients | |
| 52 patients re-questioned to answer the same questionaire as control group | The test-retest reliability of the LARS score was evaluated by asking 52 randomly selected subgroup of eligible patients to repeat the assessment of the LARS score 2 to 4 weeks after their initial response. Agreement between tests for the LARS score category and for each of the five LARS score items is presented as proportions with 95% confidence intervals. We considered it a perfect agreement if the patient ticked the exact same response category at both tests, a moderate agreement if responses differed by one category, while 'no agreement' was applied to patients whose responses differed by two or more categories.
The intraclass correlation coefficient was used to evaluate the agreement between the initial test and the retest. The limit of agreements was calculated by using the Bland-Altman method. An ICC between 0.61 and 0.80 is considered strong agreement. A "p value" less than 0.05 was considered significant. Receives: Procedure: Rectal Resection Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of LARS Score
The translated questionaire was validated on Turkish speaking patients
Measured: From Feb 2016 to Feb 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Feb 2016
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LARS - 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
- 222 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Dokuz Eylul University, Lokman Hekim University
- Responsible party
- Principal investigator, I Ethem Gecim, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289531
- Sponsor's protocol ID
- 3
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celasin H, Akyol C, Gecim IE, Halil Elhan A, Juul T, Sokmen S, Sungurtekin U, Akyuz S. Validation of the Turkish translation of the low anterior resection syndrome (LARS) score. Tech Coloproctol. 2023 Jun;27(6):465-474. doi: 10.1007/s10151-023-02751-z. Epub 2023 Jan 18.
PubMed 36650405
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Translation of the Low Anterior Resection Syndrome (LARS) Score
- ClinicalTrials.gov ID
- NCT05289531
- Acronym / sponsor ID
- 3
- Conditions
- LARS - Low Anterior Resection Syndrome
- Keywords
- Turkish LARS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Dokuz Eylul University, Lokman Hekim University
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Mar 2022 (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.
Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to measure this syndrome and its impact on quality of life in Danish patients. Recently, English and many other language versions have been validated. The aim of this study was to validate the Turkish translation of the LARS score in Turkish patients who have undergone treatment for rectal cancer.
Detailed description
A total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses. The association between the LARS score and quality of life and the test-retest reliability were studied. The intraclass correlation coefficient (ICC) was calculated to understand the degree of reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal resection patients | – | Procedure: Rectal Resection PatientsFour Turkish centers participated in data collection in 2016. The inclusion criteria were rectal adenocarcinoma within 15 cm from the anal verge and LAR with either PME or TME. All patients had bowel continuity restored for at least 18 months when invited for the study. Exclusion criteria included failed R0 surgery, recurrence or dissemination, having intestinal stoma, previous cancer (except minor skin cancers) dementia and inability to speak Turkish (i.e., the need for a translator during treatment). A research assistant at each center identified the consecutive series of eligible patients for each participating consultant surgeon |
| 52 patients re-questioned to answer the same questionaire as control group | – | Procedure: Rectal Resection PatientsThe test-retest reliability of the LARS score was evaluated by asking 52 randomly selected subgroup of eligible patients to repeat the assessment of the LARS score 2 to 4 weeks after their initial response. Agreement between tests for the LARS score category and for each of the five LARS score items is presented as proportions with 95% confidence intervals. We considered it a perfect agreement if the patient ticked the exact same response category at both tests, a moderate agreement if responses differed by one category, while 'no agreement' was applied to patients whose responses differed by two or more categories. The intraclass correlation coefficient was used to evaluate the agreement between the initial test and the retest. The limit of agreements was calculated by using the Bland-Altman method. An ICC between 0.61 and 0.80 is considered strong agreement. A "p value" less than 0.05 was considered significant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients had their surgeries performed by expert colorectal surgeons with at least 15 years of experience and performing more than 20 rectal cancer surgeries in a year to minimize surgeon-related hazards for poor functional outcome. The first rectal resection with a diverting ileostomy in the study group was performed in May 2000, which was closed in January 2001, and the last stoma closure was in September 2018. All patients had their bowel continuity restored for at least 6 months prior to completing the survey.
Key inclusion criteria (3 listed)
- rectal adenocarcinoma within 15 cm from the anal verge
- LAR with either PME or TME.
- Bowel continuity restored for at least 18 months when invited for the study.
Key exclusion criteria (5 listed)
- failed R0 surgery,
- recurrence or dissemination,
- having intestinal stoma,
- previous cancer (except minor skin cancers)
- dementia and inability to speak Turkish (i.e., the need for a translator during treatment).
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 |
|---|---|---|
| Rectal Resection PatientsPatients who have had low anterior resection of rectum was categorized for their quality of life related to surgery | Procedure or surgery | 52 patients re-questioned to answer the same questionaire as control group, Rectal resection patients |
Primary outcome
Validity of LARS Score
Time frame: From Feb 2016 to Feb 2020
The translated questionaire was validated on Turkish speaking patients
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 21 Mar 2022.
- Derived from this study: PubMed 36650405Celasin H, Akyol C, Gecim IE, Halil Elhan A, Juul T, Sokmen S, Sungurtekin U, Akyuz S. Validation of the Turkish translation of the low anterior resection syndrome (LARS) score. Tech Coloproctol. 2023 Jun;27(6):465-474. doi: 10.1007/s10151-023-02751-z. Epub 2023 Jan 18.
- Individual participant dataSharing planned: No
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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 LARS - Low Anterior Resection Syndrome, run by Ankara University.
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 3 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: finished, as of the sponsor's last update on 21 Mar 2022. 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?
Validity of LARS Score (time frame: From Feb 2016 to Feb 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289531, which also lists 1 linked publication.
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 21 Mar 2022.