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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Athens, Grécia, 11526
- General Hospital of Athens G Gennimatas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comprehensive Complication Index (CCI)
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amalia Douma, MD PHD, G.Gennimatas General Hospital
- Investigador principal: Panagiotis Chatzistavridis, MD, G.Gennimatas General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Cirurgia bariatrica
- Estratificação de risco
- CARRO
- PNI
- Gastrectomia vertical
- Bypass Gástrico
- PLR
- NLR
- Índice Nutricional Prognóstico
- Proporção de neutrófilos para linfócitos
- Classificação de Clavien-Dindo
- Índice de Resposta de Inflamação Sistêmica
- Sii
- Rácio Plaquetas-Linfócitos
- Índice de Inflamação Imune Sistémica
- C-Reactive Protein-to-Albumin Ratio
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24050/28-07-2026 (Identificador de registro: Scientific Council Approval, General Hospital G. Gennimatas, Athens, Greece)
Plano para dados de participantes individuais (IPD)
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