Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
NCT ID: NCT06603129
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
134 participants
OBSERVATIONAL
2021-10-15
2022-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors.
NCT06657599
Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer
NCT06016829
The Effect of Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Thoracic Surgery Cases
NCT05890820
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
NCT06687291
Prevalence of Malnutrition in Surgery
NCT03926715
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CROSSOVER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Delirium Group
group that developed delirium within 3 days postoperatively
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who will undergo gastrointestinal cancer surgery
* Able to give voluntary consent
* ASA I-IV patients
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muhammet Aydın Akdoğan
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gonca Oguz
Role: STUDY_DIRECTOR
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Muhammet Aydın Akdoğan
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-10/1411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.