Nutrition AssessmentNCT07374055
The Effect of Nutritional Status on Postoperative Mortality and Morbidity in the Geriatric Population Undergoing Gastrointestinal Surgery
An observational study of Nutrition Assessment and Geriatric Anesthesia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutrition Assessment, Geriatric Anesthesia
- What is being tested?
- Preoperative Risk Scoring, Postoperative Morbidite and Mortality Monitoring and Delirium Assessment Protocol
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 May 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric patients scheduled for gastrointestinal surgery at a single-center tertiary care urban hospital (SBÜ Kartal Dr. Lütfi Kırdar City Hospital).".
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Kartal, 34890
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Nutrition Assessment, Geriatric Anesthesia
- Being tested
- Preoperative Risk Scoring, Postoperative Morbidite and Mortality Monitoring, Delirium Assessment Protocol
- Keywords
- Geriatric, Nutritional, Mortality, Gastrointestinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Risk ScoringOther
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).
Postoperative Morbidite and Mortality MonitoringOther
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.
Delirium Assessment ProtocolOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Preoperative Risk Scoring; Other: Postoperative Morbidite and Mortality Monitoring; Other: Delirium Assessment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Immune-Inflammation Index (SII)
Calculated as (Platelets x Neutrophils) / Lymphocytes from preoperative blood samples.The unit of measure is cells per microliter.
Measured: 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.
Measured: 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.
Measured: Preoperative (Baseline)
Secondary outcomes (4)
Postoperative Morbidity
Monitoring of pulmonary (e.g., pneumonia, embolism) and extrapulmonary (e.g., surgical site infection, organ failure, anastomosis leak) complications
Measured: Up to 30 days post-surgery
Incidence of Delirium
Assessment of delirium using the Confusion Assessment Method (CAM/CAM-ICU) and Richmond Agitation-Sedation Scale (RASS).
Measured: Preoperative to discharge
Length of Hospital and ICU Stay
Recording the number of days spent in the hospital and intensive care unit.
Measured: Total duration of hospitalization
Postoperative Mortality Rate
Tracking patient survival rates at specified intervals after the operation.
Measured: 30, 60, and 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minel Neslihan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Minel N KUTUPOGLU SEZER, MD, Principal investigator, University of Health Sciences, Kartal Dr. Lutfi Kirdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374055
- Sponsor's protocol ID
- KARTALANESTEZİ088
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07374055
- Acronym / sponsor ID
- KARTALANESTEZİ088
- Conditions
- Nutrition Assessment, Geriatric Anesthesia
- Keywords
- Geriatric, Nutritional, Mortality, Gastrointestinal surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Gastrointestinal Surgery Patients. | – | Other: Preoperative Risk Scoring, Other: Postoperative Morbidite and Mortality Monitoring, Other: Delirium Assessment ProtocolThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric patients scheduled for gastrointestinal surgery at a single-center tertiary care urban hospital (SBÜ Kartal Dr. Lütfi Kırdar City Hospital).".
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Risk ScoringPatients 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). | Other | Geriatric Gastrointestinal Surgery Patients. |
| Postoperative Morbidite and Mortality MonitoringSystematic 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. | Other | Geriatric Gastrointestinal Surgery Patients. |
| Delirium Assessment ProtocolPatients 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). | Other | Geriatric Gastrointestinal Surgery Patients. |
Primary outcome
Systemic Immune-Inflammation Index (SII)
Time frame: Preoperative (Baseline)
Calculated as (Platelets x Neutrophils) / Lymphocytes from preoperative blood samples.The unit of measure is cells per microliter.
Geriatric Nutritional Risk Index (GNRI) as a predictor of postoperative complications
Time frame: Preoperative (Baseline)
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.
Mini Nutritional Assessment-Short Form (mNA-SF) score
Time frame: Preoperative (Baseline)
A 6-question survey to screen for malnutrition.Measured on a scale of 0 to 14 points, where 0-7 indicates malnourishment.
4 secondary outcomes
Postoperative Morbidity
Time frame: Up to 30 days post-surgery
Incidence of Delirium
Time frame: Preoperative to discharge
Length of Hospital and ICU Stay
Time frame: Total duration of hospitalization
Postoperative Mortality Rate
Time frame: 30, 60, and 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minel N KUTUPOGLU SEZER, MD principal investigator
University of Health Sciences, Kartal Dr. Lutfi Kirdar City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Assessment and Geriatric Anesthesia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Immune-Inflammation Index (SII) (time frame: Preoperative (Baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.