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The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy

NCT ID: NCT02985502

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life Diabetes Mellitus Pancreatectomy

Keywords

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Quality of Life Diabetes Mellitus Pancreatectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pancreatogenic diabetes

patients with pancreatogenic diabetes after pancreatectomy will be recruited

pancreatogenic diabetes

Intervention Type OTHER

pancreatogenic diabetes

Interventions

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pancreatogenic diabetes

pancreatogenic diabetes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiow-Ching Shun, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, College of Medicine, National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsuan-Ju Kuo, MSN

Role: CONTACT

Phone: +886-929215939

Email: [email protected]

Shiow-Ching Shun, PhD

Role: CONTACT

Phone: +886-2-23123456

Email: [email protected]

Facility Contacts

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Hsuan-Ju Kuo, MSN

Role: primary

Other Identifiers

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201611038RINB

Identifier Type: -

Identifier Source: org_study_id