Skip to main content
OpenTrials
Completed

NCT Number: NCT06603129

Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Confusion Postoperative Confusion Delirium Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhammet Aydın Akdoğan

Ankara, 06220, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prognostic nutritional index

Diagnostic Test

Prognostic nutritional index 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.

Primary outcomes

  1. 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

  1. demographic characteristics

    Time frame: 15 October 2021-15 June 2022

    Evaluation of patients' age, gender, education level and their relationship with delirium

  2. amount of bleeding

    Time frame: 15 October 2021-15 June 2022

    The relationship between the amount of bleeding and delirium

  3. biochemical parameters

    Time frame: 15 October 2021-15 June 2022

    Evaluation of the patients' lymphocyte count, hemoglobin, albumin, urea, creatinine, AST, ALT concentrations and their relationship with delirium

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.