Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery

NCT ID: NCT06603129

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-06-15

Brief Summary

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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

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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.

Conditions

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Confusion Postoperative Delirium Gastrointestinal Cancer Nutritional Deficiency

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium Group

group that developed delirium within 3 days postoperatively

prognostic nutritional index

Intervention Type 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.

Non Delirium Group

group that did not develop delirium within 3 days postoperatively

prognostic nutritional index

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Muhammet Aydın Akdoğan

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gonca Oguz

Role: STUDY_DIRECTOR

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Locations

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Muhammet Aydın Akdoğan

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33442311 (View on PubMed)

Other Identifiers

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2021-10/1411

Identifier Type: -

Identifier Source: org_study_id

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