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Clinical Trials/NCT06603129
NCT06603129
Completed
Not Applicable

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 site in 1 country134 target enrollmentStarted: October 15, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Enrollment
134
Locations
1
Primary Endpoint
Evaluation of the development of delirium

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Evaluation of the development of delirium

Time Frame: 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)

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Aydın Akdoğan

Dr.

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study Sites (1)

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