(LARS) Score Validation of Turkish Language

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.

Study Overview

• Status: Completed
• Conditions: LARS - Low Anterior Resection Syndrome
• Intervention / Treatment: Procedure: Rectal Resection Patients

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 Type: Observational
• Enrollment (Actual): 222

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:The inclusion criteria were

• 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.

Exclusion Criteria: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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Rectal Resection Patients; Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery
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.	Procedure: Rectal Resection Patients; Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of LARS Score	The translated questionaire was validated on Turkish speaking patients	From Feb 2016 to Feb 2020

Collaborators and Investigators

• Sponsor: Ankara University
• Collaborators: Aarhus University Hospital; Dokuz Eylul University; Lokman Hekim Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Turkish LARS
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No