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Validation of Low Anterior Resection Syndrome Score in Korean Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211715
Recruitment Status : Unknown
Verified July 2017 by Hyung Jin Kim, Saint Vincent's Hospital, Korea.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hyung Jin Kim, 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.

Condition or disease Intervention/treatment
Neoplasm of Rectum Surgery--Complications Surgery Other: questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Low Anterior Resection Syndrome Score in Korean Version
Estimated Study Start Date : July 19, 2017
Estimated Primary Completion Date : July 19, 2018
Estimated Study Completion Date : December 31, 2018

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


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211715


Contacts
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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
Publications:
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Responsible Party: Hyung Jin Kim, Assistant Professor, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT03211715    
Other Study ID Numbers: SVHKorea
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases