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NCT Number: NCT07007494

Early Outcomes and Nutritional Scores in Bariatric Patients

This prospective observational study aims to evaluate whether preoperative immune-nutritional markers-specifically the Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes such as time to oral intake, mobilization, complications, and length of hospital stay in patients undergoing elective laparoscopic sleeve gastrectomy.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Preoperative Nutritional Markers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location status: Recruiting

Location contact

ilke dolgun

CONTACT

[email protected]

ilke dolgun

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 65 years
Body mass index (BMI) ≥ 35 kg/m²
Scheduled for elective laparoscopic sleeve gastrectomy
Availability of complete preoperative laboratory test results
Signed informed consent

Exclusion criteria

Severe hepatic or renal dysfunction
Presence of active infection
History of immunosuppressive therapy or hematologic malignancy
Need for intensive care unit (ICU) admission within the first 72 hours postoperatively
Preoperative administration of albumin or blood products

Treatment and study plan

Nutritional and Inflammatory Marker Evaluation

Other

This is a prospective observational cohort study evaluating whether preoperative immune-nutritional markers-including Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes (complication development, time to oral intake, mobilization, and length of hospital stay) in patients undergoing elective laparoscopic sleeve gastrectomy. No intervention or treatment is administered as part of this study. All data are collected from routine preoperative laboratory tests and standard postoperative clinical follow-up.

Primary outcomes

Occurrence of Postoperative Complications Within 72 Hours

Time frame: Up to 72 hours after surgery

Complications such as fever, surgical site infection, nausea/vomiting, hypotension, or need for reintervention will be recorded during the first 72 hours after laparoscopic sleeve gastrectomy. The association between preoperative nutritional and inflammatory scores (PNI, HALP, NLR, CRP) and complication occurrence will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

ilke dolgun

CONTACT

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

The Relationship Between Preoperative Nutritional and Inflammatory Markers and Early Postoperative Clinical Outcomes in Patients Undergoing Bariatric Surgery

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 5, 2025
Registry last updated: Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting