(LARS) Score Validation of Turkish Language

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.

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Key information

Conditions

LARS - Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Low Anterior Resection Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rectal Resection Patients

Procedure

Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery

Primary outcomes

Validity of LARS Score

Time frame: From Feb 2016 to Feb 2020

The translated questionaire was validated on Turkish speaking patients

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

Aarhus University Hospital
Dokuz Eylul University
Lokman Hekim University

Registry information

Official study title

Validation of the Turkish Translation of the Low Anterior Resection Syndrome (LARS) Score

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2022
Registry last updated: Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed