Validation of Low Anterior Resection Syndrome Score in Korean Version

Surgery Clinical Trial

Official title:

Validation of Low Anterior Resection Syndrome Score in Korean Version

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03211715
• Other study ID #: SVHKorea
• Status: Not yet recruiting
• Phase: N/A
• First received: June 20, 2017
• Last updated: July 5, 2017
• Start date: July 19, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Saint Vincent's Hospital, Korea
• Contact: Ri Na Yoo, MD
• Phone: 82-10-2531-0605
• Email: ninayoo1111[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: July 19, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm of Rectum
• Rectal Neoplasms
• Surgery
• Surgery--Complications

Intervention

Other:
• questionnaire
Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

References & Publications (1)

Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in association to the severity of bowel dysfunction	The change in the quality of life will be evaluated based on the questionnaire in regard to 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