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临床试验/NCT06057207
NCT06057207已完成不适用

Effects of Perioperative Circulating Adiponectin Levels on Postoperative Systemic Inflammatory Response in Patients Undergoing Major Colorectal Surgery

Osijek University Hospital2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Adiponectin

研究概览

简要总结

Surgical stress after major abdominal surgery in perioperative period causes neuroendocrine, metabolic and imunologic changes in organism with production of proinfflamatory citokines and results with appearance of systemic infflammmatory response syndrome (SIRS). Dysregulated and overrated SIRS in early postoperative period can lead to complications with additional comorbidities, longer hospital stay and poorer outcome. A low grade chronic infflammatory state in obesity and hypoadiponectinemia can enable the cytokine storm and exaggerated /dysregulated SIRS in obese patients after surgery. Obesity according to this knowledge presents independent risk factor for developing more severe systemic infflamatory response syndrome in early postoperative period after major abdominal surgery. Also, chronic intestinal and gut infflamation is leading theory in oncogenesis of colorectal carcinoma according to recent findings. Many studies find low adiponectin levels in patients with colorectal carcinoma compared to healthy population. Obesity and colorectal cancer have infflamation and low adiponectin level as mutual factor which can be the important key in pathophysiology process of colorectal oncogenesis which are extremly complicated , multifactorial and intertwining.

Hypothesis: Lower blood adiponectin levels are associated with higher systemic infflamatory response in patients after major abdominal surgery. Major aim of this study is to investigate correlation between perioperative blood levels of adiponectin and clinical signs of systemic infflamation and blood markers of systemic infflamation in patients after major colorectal surgery.

详细描述

Gastrointestinal tumors are commonly presented for surgical resections. According to Global Cancer Statistics 2020: GLOBOCAN estimates colorectal carcinoma ranks third in terms of incidence, but second in terms of mortality for overall carcinomas worldwide. At the same time, obesity is a fast growing disease with of pandemic proportions with a current global prevalence of 39% according to the World Health Organisation (WHO). Many patients presented for major abdominal resections of colrectal carcinomas are obese. Obesity is chronic disease with complex pathophisiology. Adipose tissue besides being a storage site is responsible for secretion of various adipokines with imunometabolic role. Adipokines (also called adipocytokines) are cell-signaling molecules (cytokines) produced by the adipose tissue that play many functional roles in energy/metabolic status of the body, and inflammation. Among adipokines, adiponectin is predominantly antiinfflamatory adipokine which inhibits production of infflammatory citokines (IL-6) and is decreased in obesity. Adipocyte dysfunction in obesity with altered adipokines release results in chronic low-grade inflammatory state. Obesity is also well known risk factor for colorectal carcinoma in which oncogenesis adiponectin may be the important key according to recent findings.

Surgical stress after major colorectal surgery in perioperative period causes neuroendocrine, metabolic and imunologic changes in organism with production of proinfflamatory citokines and results with appearance of systemic infflammmatory response syndrome (SIRS). Dysregulated and overrated SIRS in early postoperative period can lead to complications with additional comorbidities, longer hospital stay and poorer outcome. A low grade chronic infflammatory state in obesity and colorectal carcinoma associated with potential hypoadiponectinemia can enable the cytokine storm and exaggerated /dysregulated SIRS in these patients after surgery. Due to this knowledge, it is logical to presume that adiponectin levels in perioperative period are associated with the intensity of systemic infflamatory response after major colorectal surgery.

Hypothesis: Perioperative blood adiponectin levels are associated with higher intensity of systemic infflamatory response in patients after major colorectal surgery.

Aim of this study is to:

  1. Measure and investigate correlation between perioperative blood adiponectin levels and appearance and intensity of systemic infflamatory response in patients after major colorectal surgery.
  2. Investigate correlation between perioperative blood adiponectin levels, SIRS and postoperative complications, days of ICU and lenght of hospital stay in patients presenting for major colrectal surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnose of colorectal cancer Age >18 years Patient presenting for major (open) elective colorectal surgery according to carcinoma.
  • Written informed consent.

排除标准

  • Age<18 years BMI<18.5kg/m2 Acute surgical conditions Established acute systemic/local infection Chronic/actual corticosteroid therapy Active immunomodulation therapy Allergie to used anestehetics/analgetics in study. Patient refusal Laparoscopic surgery Massive intraoperative surgical bleeding Preexisting concomitant second carcinoma other than colorectal origin Patients which does not fulfill inclusion criteria

结局指标

主要结局

Adiponectin

时间窗: Preoperative, 24 hours after surgery, 72 hours after surgery

Three measurements of adiponectin will be taken from blood samples of every patient preoperative, 24 and 72 hours postoperative

次要结局

  • IL-6(Preoperative, 24 hours after surgery, 72 hours after surgery)

研究者

发起方
Osijek University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonja Skiljic

Principal Investigator

Osijek University Hospital

研究点 (2)

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