NCT06603129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
2 years until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 28, 2022

Last Update Submit

September 16, 2024

Conditions

Keywords

confusiondeliriumgastrointestinal cancerprognostic nutritional index

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the development of delirium

    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 Outcomes (3)

  • 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

Study Arms (2)

Delirium Group

group that developed delirium within 3 days postoperatively

Diagnostic Test: prognostic nutritional index

Non Delirium Group

group that did not develop delirium within 3 days postoperatively

Diagnostic Test: prognostic nutritional index

Interventions

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.

Delirium GroupNon Delirium Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammet Aydın Akdoğan

Ankara, 06220, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33442311BACKGROUND

MeSH Terms

Conditions

DeliriumGastrointestinal NeoplasmsMalnutritionConfusion

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Gonca Oguz

    Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 28, 2022

First Posted

September 19, 2024

Study Start

October 15, 2021

Primary Completion

May 20, 2022

Study Completion

June 15, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations