Clinical trial NCT02985502: The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy
Official title: The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Diabetes Mellitus
Pancreatectomy
Keywords: Quality of Life
Diabetes Mellitus
Pancreatectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pancreatogenic diabetes after total pancreatectomy or pancreaticoduodenectomy

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* (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:

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

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: 1 day at first appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Nursing, College of Medicine, National Taiwan University
name: Shiow-Ching Shun, PhD
role: PRINCIPAL_INVESTIGATOR
References: