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ENROLLING BY INVITATION
NCT06774170
NA

Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery

Sponsor: Dokuz Eylul University

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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)