CClinicalTrials.gg
Active, not recruitingNCT07794722Updated Aug 31, 2026

Prognostic Nutritional Index and Postoperative Complications in Oncologic Surgery

An observational study in Prognostic Nutritional Index, sponsored by Kocaeli City Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Kocaeli City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Although PNI has been studied in various malignancies, its predictive value for postoperative outcomes across all oncologic surgical procedures has not been fully evaluated. This study aims to assess the role of PNI in predicting postoperative outcomes and prognosis in patients undergoing different types of oncologic surgery.

Read the detailed description

Anorexia, malnutrition, and cachexia are commonly observed in patients undergoing oncologic surgery . Although these issues are more pronounced in advanced-stage disease, they can also occur in early-stage malignancies and adversely affect treatment outcomes. Various methods and tests are used to assess patients' nutritional status, including the Malnutrition Universal Screening Tool (MUST) for community screening, the Nutritional Risk Screening (NRS) for hospitalized patients, and the Mini Nutritional Assessment (MNA) for elderly patients. Some of these tools are simple, consisting of only a few parameters, while others are more complex, incorporating clinical, laboratory, and technological measurements . Examples of these scales include the Subjective Global Assessment (SGA) and the Patient-Generated Subjective Global Assessment (PG-SGA) . Nutritional assessment methods have generally been reported to be useful in predicting treatment response, tolerance, and prognosis.

One such tool, the Prognostic Nutritional Index (PNI), was first proposed by Onodera et al. as a novel prognostic score based on systemic inflammation, calculated using the combination of lymphocyte count and serum albumin levels. PNI is relatively simple, relies on fewer parameters, and is easy to apply . It is calculated using the formula:

PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])

Onodera et al. demonstrated that PNI values above 45 can be used reliably, although the optimal cut-off value may vary . Hypoalbuminemia is an independent predictor of in-hospital and long-term adverse outcomes . Serum albumin (SA) is a negative marker of inflammation, as its concentration decreases in the presence of inflammatory processes . It also serves as an abundant and important circulating antioxidant, participating in ligand binding and free radical scavenging activities . Lymphocyte count reflects immune function; low lymphocyte levels have been associated with pre-existing immunosuppression, leading to inadequate immune responses in cardiovascular diseases. Patients with lymphopenia are more likely to develop endothelial dysfunction, platelet activation, and thrombogenesis. Total lymphocyte count (TLC) is an immuno-inflammatory biomarker, and lymphopenia is more likely to develop in the setting of inflammation-associated lymphocyte apoptosis .

PNI has been used as a prognostic marker in various malignancies, pulmonary embolism, and other diseases. It has been shown to be an effective indicator of nutritional and immunological status in cancer patients and to influence patient prognosis through local immune responses . Although the predictive value of PNI has been studied for postoperative mortality, treatment response, and prognosis in different oncologic surgeries, there is no study evaluating its prognostic role across all patients undergoing oncologic surgery . This study aims to assess the impact of PNI on postoperative outcomes in patients undergoing various oncologic surgical procedures.

02

Conditions studied

  • Prognostic Nutritional Index
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who met the inclusion criteria, were not excluded according to the exclusion criteria, and underwent oncologic surgery between the opening date of our hospital and the date of ethics committee approval will be included in the study.

Inclusion criteria

  • Kocaeli City Hospital, all patients over 18 years old who have undergone oncologic surgery

Exclusion criteria

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients with a history of bone marrow suppression or hematologic malignancy
  • Patients admitted as emergency cases
  • Patients who received albumin replacement within 1 month prior to surgery (preoperative period)
  • Patients who received chemotherapy/radiotherapy within the last 1 year
  • Patients who received immunosuppressive therapy within the last 1 year
  • Patients who received blood or blood product replacement within 1 month prior to surgery (preoperative period)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery.

    The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 30-day and 90-day mortality will be evaluated in patients undergoing oncologic surgery.

    Time frame: the 30-day periods following oncologic surgery

Secondary outcomes

  1. The Prognostic Nutritional Index (PNI) may be a predictor of 90-day mortality in patients undergoing oncologic surgery.

    The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery. The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery.

    Time frame: the 90-day periods following oncologic surgery

  2. Incidence of acute kidney injury

    Predictive value of preoperative PNI for the incidence of acute kidney injury within 3 months after oncologic surgery.

    Time frame: 3 months postoperatively

  3. Wound healing

    The predictive value of preoperative PNI for wound healing will be evaluated, based on assessments documented in outpatient clinic and ward notes.

    Time frame: 90 days postoperatively(assessed via outpatient and ward follow-up notes)

  4. Thromboembolic events

    The predictive value of preoperative PNI for the risk of thromboembolic events within 30 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Time frame: 30 days postoperatively

  5. Revision surgery

    The predictive value of preoperative PNI for the need for revision surgery within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Time frame: 90 days postoperatively

  6. Need for cardiopulmonary resuscitation (CPR)

    The predictive value of preoperative PNI for the need for cardiopulmonary resuscitation within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.

    Time frame: 90 days postoperatively

  7. Intraoperative and postoperative bleeding

    The predictive value of preoperative PNI for the risk of intraoperative and postoperative bleeding will be evaluated in patients undergoing oncologic surgery.

    Time frame: 30 days postoperatively

06

Study locations

1 site
  • Kocaeli Şehir Hastanesi
    Kocaeli, Izmit 41060, Turkey (Türkiye)
07

Registry details

Key details

Study ID
NCT07794722
Lead sponsor
Kocaeli City Hospital
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Mar 29, 2026
Primary completion
Dec 10, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 31, 2026

Study contacts

Ayşe Z Turan Cıvraz, Assoc. Prof.
principal investigator · kocaeli şehir hastanesi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion