跳至主要内容
临床试验/NCT03211715
NCT03211715Unknown不适用

Validation of Low Anterior Resection Syndrome Score in Korean Version

Saint Vincent's Hospital, Korea0 个研究点目标入组 300 人开始时间: 2017年7月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Quality of life in association to the severity of bowel dysfunction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • age 20-80
  • surgery undertook from Jan. 2009 to Dec. 2016
  • diagnosed with adenocarcinoma
  • curative intent of surgery
  • planned surgery
  • sphincter saving surgery

排除标准

  • patients with stage IV
  • emergency surgery
  • patients with recurrent disease

结局指标

主要结局

Quality of life in association to the severity of bowel dysfunction

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Saint Vincent's Hospital, Korea
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung Jin Kim

Assistant Professor

Saint Vincent's Hospital, Korea

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