跳至主要内容
临床试验/NCT06603129
NCT06603129已完成不适用

Evaluation of the Relationship Between Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2021年10月15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
134
试验地点
1
主要终点
Evaluation of the development of delirium

研究概览

简要总结

Aim:

We aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.

Materials and Methods:

Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.

详细描述

Aim:

Malnutrition, common among gastrointestinal cancer patients, affects morbidity and mortality. Prognostic nutritional index (PNI) is an inflammation-based scoring that measures the nutritional and immunological status of patients and has been used to determine prognosis and predict postoperative complications. Postoperative delirium (POD) describes a neurocognitive complication that may occur after surgery and anesthesia. Most of the studies examining the relationship between PNI and POD are retrospective and the number of prospective large case series are insufficient.

In this study, we aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.

Materials and Methods

Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

  • Patients aged 18 and over
  • Patients who will undergo gastrointestinal cancer surgery
  • Able to give voluntary consent
  • ASA I-IV patients

排除标准

  • Under 18 years old
  • Those who do not agree to be included in the study
  • Unconscious
  • Hearing, sight and speech impaired
  • Chronic alcohol user
  • Patients with cognitive or psychiatric disorders such as known dementia, Parkinson's, Alzheimer's
  • Patients who need postoperative mechanical ventilation support

结局指标

主要结局

Evaluation of the development of delirium

时间窗: 15 October 2021-20 May 2022

Evaluation of whether delirium develops in postoperative patients within the first 3 days using the Confusion Assessment Method (CAM)

次要结局

  • demographic characteristics(15 October 2021-15 June 2022)
  • amount of bleeding(15 October 2021-15 June 2022)
  • biochemical parameters(15 October 2021-15 June 2022)

研究者

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammet Aydın Akdoğan

Dr.

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (1)

Loading locations...

相似试验