- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07747168
Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications After Bariatric Surgery (BARI-NUTRI)
The Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications in Bariatric Surgery Patients: A Single-Centre Retrospective Cohort Study
Bariatric surgery is an effective treatment for severe obesity, but postoperative complications remain an important cause of morbidity. Several nutritional and inflammatory biomarkers derived from routine preoperative blood tests have been proposed as predictors of postoperative outcomes; however, their comparative value in bariatric surgery has not been fully established.
This single-center retrospective cohort study will evaluate the ability of preoperative nutritional and inflammatory indices, including the Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), and C-reactive Protein-to-Albumin Ratio (CAR), to predict 30-day postoperative complications following bariatric surgery. The study aims to identify the most clinically useful biomarker for preoperative risk stratification and optimization of perioperative care.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Bariatric surgery is the most effective treatment for severe obesity and obesity-related comorbidities. Despite advances in perioperative care, early postoperative complications continue to contribute to patient morbidity and healthcare utilization. Reliable preoperative risk stratification tools are therefore essential for identifying patients at increased risk and optimizing perioperative management.
Nutritional status and systemic inflammation have emerged as important determinants of surgical outcomes. Several composite indices calculated from routinely available laboratory parameters, including albumin, C-reactive protein, leukocyte subsets, and platelet counts, have demonstrated prognostic value in different surgical populations. However, evidence regarding their comparative predictive performance in bariatric surgery remains limited.
This single-center retrospective cohort study will include consecutive adult patients who underwent sleeve gastrectomy or gastric bypass procedures between 2023 and 2026. Preoperative nutritional and inflammatory indices (PNI, NLR, PLR, SII, SIRI, and CAR) will be calculated from the most recent preoperative laboratory values.
The primary outcome is the occurrence of any Clavien-Dindo grade II or higher postoperative complication within 30 days after surgery. Secondary outcomes include the Comprehensive Complication Index (CCI), length of hospital stay, intensive care unit admission, and 30-day mortality. Multivariable regression analyses will be performed to determine the independent predictive value of each index after adjustment for relevant demographic and clinical variables.
The findings of this study are expected to improve preoperative risk assessment and facilitate identification of patients who may benefit from targeted perioperative optimization strategies.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Athens, Grèce, 11526
- General Hospital of Athens G Gennimatas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Adults aged 18 years or older.
- Patients who underwent bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass, SADI, or SASI).
- Availability of complete preoperative laboratory data required for calculation of nutritional and inflammatory indices.
- Availability of postoperative follow-up data for assessment of 30-day complications.
Exclusion Criteria:
Patients younger than 18 years.
- Missing key preoperative laboratory values required to calculate study indices.
- Incomplete medical records or unavailable 30-day postoperative outcome data.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Bariatric Surgery Cohort
Adult patients who underwent bariatric surgery (sleeve gastrectomy or gastric bypass procedures including Roux-en-Y gastric bypass, SADI, and SASI) between 2023 and 2026.
Preoperative nutritional and inflammatory indices were evaluated for their association with 30-day postoperative complications.
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Standard bariatric surgical procedures performed as part of routine clinical care, including sleeve gastrectomy and gastric bypass procedures (Roux-en-Y gastric bypass, SADI, and SASI).
No study-specific intervention was assigned.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)
Délai: 30 days after surgery
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Occurrence of any postoperative complication classified as Clavien-Dindo grade II or higher within 30 days after bariatric surgery.
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30 days after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comprehensive Complication Index (CCI)
Délai: 30 days after surgery
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Comprehensive Complication Index calculated from all postoperative complications occurring within 30 days after surgery.
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30 days after surgery
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Length of Hospital Stay
Délai: From surgery until hospital discharge (up to 30 days)
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Total duration of hospitalization following bariatric surgery.
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From surgery until hospital discharge (up to 30 days)
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From surgery until hospital discharge (up to 30 days)
Délai: 30 days after surgery
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All-cause mortality occurring within 30 days after bariatric surgery.
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30 days after surgery
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amalia Douma, MD PHD, G.Gennimatas General Hospital
- Chercheur principal: Panagiotis Chatzistavridis, MD, G.Gennimatas General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Chirurgie bariatrique
- Stratification des risques
- AUTO
- PNI
- Sleeve Gastrectomie
- Pontage gastrique
- DPP
- NLR
- Indice nutritionnel pronostique
- Rapport neutrophiles/lymphocytes
- Classement Clavien-Dindo
- Indice de réponse à l'inflammation systémique
- Sii
- Rapplet plaquettes-lymphocytes
- Indice Systémique d'Inflammation Immunitaire
- C-Reactive Protein-to-Albumin Ratio
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24050/28-07-2026 (Identificateur de registre: Scientific Council Approval, General Hospital G. Gennimatas, Athens, Greece)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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