Validation of Low Anterior Resection Syndrome Score in Korean Version
1 other identifier
observational
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Start
First participant enrolled
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 7, 2017
July 1, 2017
1 year
June 20, 2017
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction
Eligibility Criteria
Rectal cancer patients who underwent sphincter preserving surgery from Jan. 2009 to Dec. 2016 will be included. Patients who are in use of stoma despite of preserved sphincter, are with recurrent disease, or in systemic metastasis, who underwent emergency surgery will not be included.
You may qualify if:
- age 20-80
- surgery undertook from Jan. 2009 to Dec. 2016
- diagnosed with adenocarcinoma
- curative intent of surgery
- planned surgery
- sphincter saving surgery
You may not qualify if:
- patients with stage IV
- emergency surgery
- patients with recurrent disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 24819098BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 20, 2017
First Posted
July 7, 2017
Study Start
July 19, 2017
Primary Completion
July 19, 2018
Study Completion
December 31, 2018
Last Updated
July 7, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share