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

Официальное название

Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• HbA1c [Срок оценки: Three months]
• fasting blood glucose [Срок оценки: Three months]
• mean glucose [Срок оценки: Three months]
• glucose standard deviation [Срок оценки: Three months]
• glucose variance coefficient [Срок оценки: Three months]
• GMI-glucose management indicator [Срок оценки: Three months]
• time spent at the target glucose value (Time in range) [Срок оценки: Three months]

Вторичные конечные точки (6)

• rehospitalization/having surgery [Срок оценки: Three months]
• wound site complications [Срок оценки: Three months]
• post-operative complications [Срок оценки: Three months]
• pain [Срок оценки: Three months]
• quality of life-EORTC QOL-C30 [Срок оценки: Three months]
• quality of life-PAN26 [Срок оценки: Three months]

Критерии участия

Критерии включения

The inclusion criteria for the particioants were; being over 18 years of age, being a smartphone user compatible with the Dexcom G6 application, having an internet connection, having a Mini Mental Test result of over 22 points for educated individuals and over 19 points for uneducated individuals, being willing to participate in the study, and having undergone pancreaticoduodenectomy.

In the study, "able to swallow table" is not eligibility criteria due to tablet (medication) adherence is not assssed In the study, patients with and without preoperative diabetes mellitus type II were included in the sample. Block randomization was performed according to the presence of DM. Therefore, the presence of diabetes is not an exclusion criterion.

In the literature, thyroid disease has not been identified as an exclusion criterion in studies related to pancreatogenic diabetes. The endocrinologist involved in this project did not find it necessary to add thyroid disease as an exclusion criterion.

Критерии исключения

Exclusion criteria were; having developed sepsis after surgery, having been diagnosed with insulinoma, glycogonoma, ectopic ACTH syndrome before surgery, having been diagnosed with a psychiatric disease, clinical diagnosis of Alzheimer's Disease and being hospitalized.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Dokuz Eylul University — Izmir

Идентификаторы

NCT: NCT06774170 · 223S838 · TUBITAK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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