Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants do not know which group they are in. Both groups are included in the study in parallel. Both groups will be monitored continuously with a glucose device. The researcher will allocate equal time to both groups. Both groups will be called with the same frequency and the same time will be allocated for these interviews. The control group will receive routine post-operative training. The follow-up intervention initiative developed will be applied to the intervention group.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Structured follow-up intervention will be performed
干预措施: structured follow-up intervention (Behavioral)
Control group
Routine post-operative follow-up and education will be applied.
结局指标
主要结局
HbA1c
时间窗: Three months
HbA1c
fasting blood glucose
时间窗: Three months
fasting blood glucose
GMI-glucose management indicator
时间窗: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
mean glucose
时间窗: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose standard deviation
时间窗: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose variance coefficient
时间窗: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
time spent at the target glucose value (Time in range)
时间窗: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
次要结局
- wound site complications(Three months)
- rehospitalization/having surgery(Three months)
- pain(Three months)
- quality of life-EORTC QOL-C30(Three months)
- quality of life-PAN26(Three months)
- post-operative complications(Three months)
研究者
Yaprak S. Ordin
Principal Investigator
Dokuz Eylul University