NCT07374055

Brief Summary

The purpose of this study was to compare the sensitivity and specificity of the Geriatric Nutritional Risk Index (GNRI), Mini Nutritional Assessment Scale-Short Form (mNA-SF) and Systemic Immune-Inflammatory Index (SII) values calculated in the preoperative evaluation in patients over 65 years of age who underwent gastrointestinal surgery, in predicting morbidity and mortality in the postoperative period.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025May 2026

Study Start

First participant enrolled

February 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

January 20, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

GeriatricNutritionalMortalityGastrointestinal surgery

Outcome Measures

Primary Outcomes (3)

  • Systemic Immune-Inflammation Index (SII)

    Calculated as (Platelets x Neutrophils) / Lymphocytes from preoperative blood samples.The unit of measure is cells per microliter.

    Preoperative (Baseline)

  • Geriatric Nutritional Risk Index (GNRI) as a predictor of postoperative complications

    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.

    Preoperative (Baseline)

  • Mini Nutritional Assessment-Short Form (mNA-SF) score

    A 6-question survey to screen for malnutrition.Measured on a scale of 0 to 14 points, where 0-7 indicates malnourishment.

    Preoperative (Baseline)

Secondary Outcomes (4)

  • Postoperative Morbidity

    Up to 30 days post-surgery

  • Incidence of Delirium

    Preoperative to discharge

  • Length of Hospital and ICU Stay

    Total duration of hospitalization

  • Postoperative Mortality Rate

    30, 60, and 90 days post-surgery

Study Arms (1)

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.

Other: Preoperative Risk ScoringOther: Postoperative Morbidite and Mortality MonitoringOther: Delirium Assessment Protocol

Interventions

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).

Geriatric Gastrointestinal Surgery Patients.

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).

Geriatric Gastrointestinal Surgery Patients.

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.

Geriatric Gastrointestinal Surgery Patients.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric patients scheduled for gastrointestinal surgery at a single-center tertiary care urban hospital (SBÜ Kartal Dr. Lütfi Kırdar City Hospital).".

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, 34890, Turkey (Türkiye)

Location

Study Officials

  • Minel N KUTUPOGLU SEZER, MD

    University of Health Sciences, Kartal Dr. Lutfi Kirdar City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 28, 2026

Study Start

February 1, 2025

Primary Completion

February 1, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 6 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations