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临床试验/NCT02985502
NCT02985502Unknown不适用

The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Quality of Life Questionnaire

研究概览

简要总结

Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. In addition, with better understanding of benign pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the quality of life of patients with pancreatogenic diabetes after TP is still currently controversial.

Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care activities and quality of life in patients with pancreatogenic diabetes after total pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.

Method: A correlational and comparative cross-sectional approach will be used. The data will be collected with a structured questionnaire via purposive sampling of 120 subjects in an outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent. Exclusion criteria will be the patients diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go through propensity score matching and will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.

Anticipated achievement: The anticipated achievement of this study is to understand the relationships between fatigue, self-care activities, and quality of life in patients with pancreatogenic diabetes after pancreas surgery. In addition, through this study, the influence of diabetes to patients after pancreatic tumor resection can be explored; and the factors that influence the population's quality of life can be examined. By the filling of this knowledge gap, intervention can be planned accordingly to help improve the population's quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent

排除标准

  • diagnosed with cancer other than pancreatic cancer and under active treatment

结局指标

主要结局

Quality of Life Questionnaire

时间窗: 1 day at first appointment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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