Validation of Low Anterior Resection Syndrome Score in Korean Version

• Conditions: Surgery; Neoplasm of Rectum; Surgery--Complications

• Registration Number: NCT03211715
• Lead Sponsor: Saint Vincent's Hospital, Korea

Brief Summary

In contemporary era of rectal cancer treatment, development of surgical technique and tool, adaptation of chemoradiation therapy, as well as multidisciplinary approach have led increased survival as well as rate of sphincter preservation. However, poor anorectal function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40 to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior resection syndrome is known to debilitate quality of life in survivors of rectal cancer. Previously, several studies attempted to evaluate the low anterior resection syndrome via questionnaires and scoring system. Adapting the low anterior resection syndrome score system created in Denmark, this study investigates the validity of the scoring system in Korean language.

Detailed Description

In this study, the low anterior resection syndrome score questionnaire proposed by Therese Juul is translated to Korean language by 3 different professional translators. Patients who received sphincter saving surgery to treat rectal cancer will be asked to fill up the questionnaire. Compiling the results, the quality of life after sphincter preserving surgery will be investigated in the association with the low anterior resection syndrome.

Study Timeline

• Study First Submitted: 2017-06-20
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Study Start: 2017-07-19
• Primary Completion: 2018-07-19
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age 20-80
• surgery undertook from Jan. 2009 to Dec. 2016
• diagnosed with adenocarcinoma
• curative intent of surgery
• planned surgery
• sphincter saving surgery

Exclusion Criteria

• patients with stage IV
• emergency surgery
• patients with recurrent disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life in association to the severity of bowel dysfunction	3 months follow-up, 6 months follow-up, 1 year follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, beyond 5 year follow-up	The change in the quality of life will be evaluated based on the questionnaire in regard to bowel dysfunction