- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374055
The Effect of Nutritional Status on Postoperative Mortality and Morbidity in the Geriatric Population Undergoing Gastrointestinal Surgery
Effects of the Geriatric Nutritional Risk Index (GNRI), Mini Nutritional Assessment-Short Form (mNA-SF), and Systemic Immune-Inflammation Index (SII) on Postoperative Morbidity and Mortality in Geriatric Patients Undergoing Gastrointestinal Surgery
Study Overview
Status
Conditions
Detailed Description
It is crucial to evaluate the impact of nutritional status and systemic inflammation markers on postoperative outcomes in geriatric patients undergoing gastrointestinal surgery.
Nutritional status has a decisive impact on the development of morbidity and mortality in geriatric patients. The risk of malnutrition is particularly high in the geriatric patient population undergoing gastrointestinal surgery. Predicting postoperative outcomes in these patient groups is becoming increasingly important. To this end, many different risk scoring systems have been developed.
Low nutritional scores and increased inflammatory responses are associated with high mortality, prolonged hospitalization and intensive care unit stays, and complications. The primary goal of preoperative risk scoring is to predict potential complications before, during, and after surgery, and to minimize risks and mortality by attempting to prevent them.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye), 34890
- Kartal Dr. Lütfi Kirdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients scheduled to undergo gastrointestinal surgery.
Age 65 years and older.
ASA (American Society of Anesthesiologists) physical status class 3 or 4.
Mini-Mental State Examination (MMSE) score of 21 or higher
Exclusion Criteria:
- Patients who do not consent to participate in the study.
Patients with acute infection during the preoperative period.
Patients who received albumin replacement in the preoperative period.
Patients with a Mini-Mental State Examination (MMSE) score below 21.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Geriatric Gastrointestinal Surgery Patients.
This group consists of 200 geriatric patients aged 65 and older who are scheduled to undergo gastrointestinal surgery.
Participants are within the ASA 3-4 risk groups and must have a Mini-Mental State Examination (MMSE) score of 21 or higher to be included.
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Patients will be evaluated preoperatively using three distinct scoring systems: the Geriatric Nutritional Risk Index (GNRI), the Mini Nutritional Assessment-Short Form (mNA-SF), and the Systemic Immune-Inflammation Index (SII).
These scores are calculated based on serum albumin levels, body weight, a 6-question survey, and laboratory values (platelets, neutrophils, and lymphocytes).
Systematic tracking of postoperative outcomes including hospital and ICU stay duration, pulmonary complications (e.g., pneumonia, embolism), extrapulmonary complications (e.g., surgical site infection, organ failure, delirium), and mortality rates at 30, 60, and 90 days.
Patients will be monitored for delirium preoperatively, on the first postoperative day, and before discharge using the Confusion Assessment Method (CAM/CAM-ICU) and the Richmond Agitation-Sedation Scale (RASS).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Systemic Immune-Inflammation Index (SII)
Time Frame: Preoperative (Baseline)
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Calculated as (Platelets x Neutrophils) / Lymphocytes from preoperative blood samples.The unit of measure is cells per microliter.
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Preoperative (Baseline)
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Geriatric Nutritional Risk Index (GNRI) as a predictor of postoperative complications
Time Frame: Preoperative (Baseline)
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GNRI will be calculated using serum albumin and body weight.
Scores will be used to categorize patients' nutritional risk.Units on a scale of 0 to 120, where lower scores indicate higher nutritional risk.
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Preoperative (Baseline)
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Mini Nutritional Assessment-Short Form (mNA-SF) score
Time Frame: Preoperative (Baseline)
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A 6-question survey to screen for malnutrition.Measured on a scale of 0 to 14 points, where 0-7 indicates malnourishment.
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Preoperative (Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Morbidity
Time Frame: Up to 30 days post-surgery
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Monitoring of pulmonary (e.g., pneumonia, embolism) and extrapulmonary (e.g., surgical site infection, organ failure, anastomosis leak) complications
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Up to 30 days post-surgery
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Incidence of Delirium
Time Frame: Preoperative to discharge
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Assessment of delirium using the Confusion Assessment Method (CAM/CAM-ICU) and Richmond Agitation-Sedation Scale (RASS).
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Preoperative to discharge
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Length of Hospital and ICU Stay
Time Frame: Total duration of hospitalization
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Recording the number of days spent in the hospital and intensive care unit.
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Total duration of hospitalization
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Postoperative Mortality Rate
Time Frame: 30, 60, and 90 days post-surgery
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Tracking patient survival rates at specified intervals after the operation.
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30, 60, and 90 days post-surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Minel N KUTUPOGLU SEZER, MD, University of Health Sciences, Kartal Dr. Lutfi Kirdar City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KARTALANESTEZİ088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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