(LARS) Score Validation of Turkish Language

NCT05289531 | Completed

• 1 other identifier: 3
• Study Type: observational
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

LARS - Low Anterior Resection Syndrome

Keywords

Turkish LARS

Outcome Measures

Primary Outcomes (1)

• Validity of LARS Score

  The translated questionaire was validated on Turkish speaking patients

  From Feb 2016 to Feb 2020

Study Arms (2)

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

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

Interventions

Rectal Resection Patients PROCEDURE

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; Rectal resection patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ankara University: lead
• Aarhus University Hospital: collaborator
• Dokuz Eylul University: collaborator
• Lokman Hekim University: collaborator

Related Publications (1)

• 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.

  PMID: 36650405 DERIVED

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 21, 2022
• Study Start: February 1, 2016
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share