(LARS) Score Validation of Turkish Language

Ankara University

Status: Completed

Conditions: LARS - Low Anterior Resection Syndrome

Treatments: Procedure: Rectal Resection Patients

Study type: Observational

Funder types: Other

Identifiers

NCT05289531

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

222 participants in 2 patient groups

Rectal resection patients

Description:

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

Treatment:

Procedure: Rectal Resection Patients

52 patients re-questioned to answer the same questionaire as control group

Description:

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.

Treatment:

Procedure: Rectal Resection Patients