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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Athens, Grecia, 11526
- General Hospital of Athens G Gennimatas
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)
Periodo de tiempo: 30 days after surgery
|
Occurrence of any postoperative complication classified as Clavien-Dindo grade II or higher within 30 days after bariatric surgery.
|
30 days after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comprehensive Complication Index (CCI)
Periodo de tiempo: 30 days after surgery
|
Comprehensive Complication Index calculated from all postoperative complications occurring within 30 days after surgery.
|
30 days after surgery
|
|
Length of Hospital Stay
Periodo de tiempo: From surgery until hospital discharge (up to 30 days)
|
Total duration of hospitalization following bariatric surgery.
|
From surgery until hospital discharge (up to 30 days)
|
|
From surgery until hospital discharge (up to 30 days)
Periodo de tiempo: 30 days after surgery
|
All-cause mortality occurring within 30 days after bariatric surgery.
|
30 days after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amalia Douma, MD PHD, G.Gennimatas General Hospital
- Investigador principal: Panagiotis Chatzistavridis, MD, G.Gennimatas General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Cirugía bariátrica
- Estratificación del riesgo
- COCHE
- PNI
- Banda gástrica
- Bypass gástrico
- Derecho de préstamo público
- NLR
- Índice nutricional pronóstico
- Proporción de neutrófilos a linfocitos
- Clasificación de Clavien-Dindo
- Índice de Respuesta a la Inflamación Sistémica
- Sii
- Relación Plaquetas-Linfocitos
- Índice de Inflamación Sistémica Inmune
- C-Reactive Protein-to-Albumin Ratio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24050/28-07-2026 (Identificador de registro: Scientific Council Approval, General Hospital G. Gennimatas, Athens, Greece)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .