Clinical trial NCT06603129: Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
Official title: Evaluation of the Relationship Between Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Confusion Postoperative
Delirium
Gastrointestinal Cancer
Nutritional Deficiency
Keywords: confusion
delirium
gastrointestinal cancer
prognostic nutritional index
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the development of delirium
timeFrame: 15 October 2021-20 May 2022
Secondary outcomes:
measure: demographic characteristics
timeFrame: 15 October 2021-15 June 2022
measure: amount of bleeding
timeFrame: 15 October 2021-15 June 2022
measure: biochemical parameters
timeFrame: 15 October 2021-15 June 2022
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Muhammet Aydın Akdoğan
Study officials:
affiliation: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
name: Gonca Oguz
role: STUDY_DIRECTOR
References:
citation: Liu H, Dai M, Guan H, Gao X, Zhou Y, Sun X, Zhou J, Hu X, Li X, Song Y, Han Y, Cao J. Preoperative Prognostic Nutritional Index Value is Related to Postoperative Delirium in Elderly Patients After Noncardiac Surgery: A Retrospective Cohort Study. Risk Manag Healthc Policy. 2021 Jan 6;14:1-8. doi: 10.2147/RMHP.S280567. eCollection 2021.