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Validation of Low Anterior Resection Syndrome Score in Korean Version
This study is not yet open for participant recruitment.
Verified July 2017 by Hyung Jin Kim, Saint Vincent's Hospital, Korea
Sponsor:
Saint Vincent's Hospital, Korea
Information provided by (Responsible Party):
Hyung Jin Kim, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier:
NCT03211715
First received: June 20, 2017
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Neoplasm of Rectum Surgery--Complications Surgery | Other: questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of Low Anterior Resection Syndrome Score in Korean Version |
Further study details as provided by Hyung Jin Kim, Saint Vincent's Hospital, Korea:
Primary Outcome Measures:
- Quality of life in association to the severity of bowel dysfunction [ Time Frame: 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
| Estimated Enrollment: | 300 |
| Anticipated Study Start Date: | July 19, 2017 |
| Estimated Study Completion Date: | December 31, 2018 |
| Estimated Primary Completion Date: | July 19, 2018 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: questionnaire
Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT03211715
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211715
Contacts
| Contact: Ri Na Yoo, MD | 82-10-2531-0605 | ninayoo1111@gmail.com | |
| Contact: Hyungjin Kim, MD, Ph.D | 82-249-7170 | hj@catholic.ac.kr |
Sponsors and Collaborators
Saint Vincent's Hospital, Korea
More Information
Publications:
| Responsible Party: | Hyung Jin Kim, Assistant Professor, Saint Vincent's Hospital, Korea |
| ClinicalTrials.gov Identifier: | NCT03211715 History of Changes |
| Other Study ID Numbers: |
SVHKorea |
| Study First Received: | June 20, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on July 11, 2017