Early Outcomes and Nutritional Scores in Bariatric Patients

NCT07007494 | Recruiting

• 1 other identifier: PNI HALP OBESITY
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Preoperative Nutritional Markers

Outcome Measures

Primary Outcomes (1)

• Occurrence of Postoperative Complications Within 72 Hours

  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.

  Up to 72 hours after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients aged 18-65 years with morbid obesity (BMI ≥ 35 kg/m²) who are scheduled to undergo elective laparoscopic sleeve gastrectomy at a tertiary care center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metabolic/bariatric surgery in adults. BMJ. 2023 Dec 18;383:e071027. doi: 10.1136/bmj-2022-071027.

  PMID: 38110235 RESULT

• Ishiguro T, Aoyama T, Ju M, Kazama K, Fukuda M, Kanai H, Sawazaki S, Tamagawa H, Tamagawa A, Cho H, Hara K, Numata M, Hashimoto I, Maezawa Y, Segami K, Oshima T, Saito A, Yukawa N, Rino Y. Prognostic Nutritional Index as a Predictor of Prognosis in Postoperative Patients With Gastric Cancer. In Vivo. 2023 May-Jun;37(3):1290-1296. doi: 10.21873/invivo.13207.

  PMID: 37103068 RESULT

• Xu F, Meng C, Yang Z, Li H, Gao J, Sun L, Zhang X, Wei Q, Wu G, Yao H, Zhang Z. Prognostic nutrition index predicts short-term surgical complications in patients with rectal cancer after laparoscopic surgery. Front Surg. 2022 Oct 25;9:1000108. doi: 10.3389/fsurg.2022.1000108. eCollection 2022.

  PMID: 36386497 RESULT

• Lee JY, Kim HI, Kim YN, Hong JH, Alshomimi S, An JY, Cheong JH, Hyung WJ, Noh SH, Kim CB. Clinical Significance of the Prognostic Nutritional Index for Predicting Short- and Long-Term Surgical Outcomes After Gastrectomy: A Retrospective Analysis of 7781 Gastric Cancer Patients. Medicine (Baltimore). 2016 May;95(18):e3539. doi: 10.1097/MD.0000000000003539.

  PMID: 27149460 RESULT

• Demirpolat MT, Sisik A. Effectiveness of the Modified Hemoglobin, Albumin, Lymphocyte, and Platelet Score in Predicting Weight Loss After Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2024 Jan;34(1):61-66. doi: 10.1089/lap.2023.0333. Epub 2023 Oct 25.

  PMID: 37878772 RESULT

• Radkhah H, Zooravar D, Shateri-Amiri B, Saffar H, Najjari K, Hazaveh MM. Predictive Value of Complete Blood Count (CBC)-Derived Indices-C-Reactive-Protein-Albumin-Lymphocyte index (CALLY), Glucose-to-Lymphocyte Ratio (GLR), Prognostic Nutritional Index (PNI), Hemoglobin, Albumin, Lymphocyte, Platelet (HALP), and Controlling Nutritional Status (COUNT)-on Body Composition Changes After Bariatric Surgery. Obes Surg. 2025 Feb;35(2):544-555. doi: 10.1007/s11695-024-07643-1. Epub 2025 Jan 8.

  PMID: 39775392 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

ilke dolgun

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 2, 2025
• Primary Completion: August 2, 2025
• Study Completion: August 15, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)