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Validation of Low Anterior Resection Syndrome Score in Korean Version

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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

Tracking Information
First Submitted Date June 20, 2017
First Posted Date July 7, 2017
Last Update Posted Date July 7, 2017
Estimated Study Start Date July 19, 2017
Estimated Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Low Anterior Resection Syndrome Score in Korean Version
Official Title Validation of Low Anterior Resection Syndrome Score in Korean Version
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Neoplasm of Rectum
  • Surgery--Complications
  • Surgery
Intervention Other: questionnaire
Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 5, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211715
Other Study ID Numbers SVHKorea
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hyung Jin Kim, Saint Vincent's Hospital, Korea
Study Sponsor Saint Vincent's Hospital, Korea
Collaborators Not Provided
Investigators Not Provided
PRS Account Saint Vincent's Hospital, Korea
Verification Date July 2017