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Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery
Sponsor: Dokuz Eylul University
Summary
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
Official title: Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-04-01
Completion Date
2026-06-01
Last Updated
2025-01-23
Healthy Volunteers
No
Conditions
Interventions
structured follow-up intervention
The intervention has been created in light of the studies including type 1 and type 2 diabetes patients and experiences of the project team with patients after PD. Theoretical background of the intervention is based on the interventions developed for glucose management in type 1 and type 2 diabetes patients and the effect of the intervention will be evaluated by using the "plan-do-check-act" model.
Locations (1)
Dokuz Eylul University
Izmir, Balcova Inciralti, Turkey (Türkiye)