Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery

September 16, 2024 updated by: Muhammet Aydın Akdoğan, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Evaluation of the Relationship Between 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06220
        • Muhammet Aydın Akdoğan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A total of 136 patients aged 18 years and older, who would undergo gastrointestinal cancer surgery and who could give voluntary consent, were included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Delirium Group
group that developed delirium within 3 days postoperatively
Diagnostic test: prognostic nutritional index
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.
Non Delirium Group
group that did not develop delirium within 3 days postoperatively
Diagnostic test: prognostic nutritional index
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
15 October 2021-20 May 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic characteristics
Time Frame: 15 October 2021-15 June 2022
Evaluation of patients' age, gender, education level and their relationship with delirium
15 October 2021-15 June 2022
amount of bleeding
Time Frame: 15 October 2021-15 June 2022
The relationship between the amount of bleeding and delirium
15 October 2021-15 June 2022
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
15 October 2021-15 June 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Investigators

  • Study Director: Gonca Oguz, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-10/1411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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