Early Outcomes and Nutritional Scores in Bariatric Patients

NCT ID: NCT07007494

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2025-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Complications Preoperative Nutritional Markers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Nutritional and Inflammatory Marker Evaluation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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İlke Dolgun

Assoc. prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istinye Üniversity

Istanbul, Merkez Mahallesi, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ilke dolgun

Role: CONTACT

+905555485632

ilke dolgun

Role: CONTACT

Facility Contacts

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ilke dolgun

Role: primary

ilke dolgun

Role: backup

References

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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.

Reference Type RESULT
PMID: 38110235 (View on PubMed)

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.

Reference Type RESULT
PMID: 37103068 (View on PubMed)

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.

Reference Type RESULT
PMID: 36386497 (View on PubMed)

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.

Reference Type RESULT
PMID: 27149460 (View on PubMed)

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.

Reference Type RESULT
PMID: 37878772 (View on PubMed)

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.

Reference Type RESULT
PMID: 39775392 (View on PubMed)

Other Identifiers

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PNI HALP OBESITY

Identifier Type: -

Identifier Source: org_study_id

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