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- Ensayo clínico NCT07688265
Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery (OBESPINE)
Effect of Obesity Phenotype on Intraabdominal Pressure, Intraoperative Bleeding, and Perioperative Complications in Patients Undergoing Major Lumbar Spinal Surgery: A Prospective Observational Study
Obesity is prevalent among patients with lumbar degenerative disease and is a known risk factor for perioperative complications in spinal surgery. However, most existing evidence relies solely on body mass index (BMI) without distinguishing between central and peripheral obesity phenotypes. Central and peripheral fat distribution may have distinct biomechanical and hemodynamic consequences, particularly with respect to intraabdominal pressure (IAP) changes during prone positioning and intraoperative blood loss.
This prospective single-center observational study aims to evaluate the effect of obesity phenotype - classified as non-obese, centrally obese, or peripherally obese based on BMI and waist-to-hip ratio - on intraabdominal pressure, intraoperative blood loss, and other perioperative outcomes in adult patients undergoing major lumbar spinal surgery (decompression and/or instrumentation)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Major lumbar spinal surgery, including lumbar canal stenosis decompression and instrumented fusion, is associated with substantial intraoperative blood loss and notable perioperative morbidity. Obesity is highly prevalent in this patient population due to its role in lumbar degenerative disease pathogenesis. Prone positioning during surgery significantly increases intraabdominal pressure, which in turn may impair venous drainage from the spinal epidural plexus, thereby augmenting operative blood loss. While BMI has been studied as a predictor of spinal surgical outcomes, the differential impact of fat distribution pattern (central vs. peripheral obesity) on IAP dynamics and bleeding has not been adequately characterized.
Study Design:
Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital and Asaf Ataseven Hospital, Istanbul, Turkey. No interventions beyond routine clinical anesthesia practice will be performed.
Patient Groups:
Patients will be categorized into three groups based on BMI and waist-to-hip ratio (WHR):
- Group NO (Non-obese): BMI <30 kg/m² (n=30)
- Group PO (Peripheral obese): BMI ≥30 kg/m² and WHR <0.85 (n=30)
- Group CO (Central obese): BMI ≥30 kg/m² and WHR ≥0.85 (n=30)
Anesthetic Protocol:
All patients will receive standard intraoperative monitoring (ECG, non-invasive blood pressure, pulse oximetry, end-tidal CO₂, BIS). Anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg, and maintained with total intravenous anesthesia (TIVA) using propofol and remifentanil infusion, consistent with the institutional protocol for neuromonitoring-guided spinal surgery. Adjusted body weight will be used for drug dosing in obese patients.
Intraabdominal Pressure Measurement:
IAP will be measured via urinary bladder catheter (standard intravesical technique) at three time points: (1) supine position after intubation, (2) prone position, and (3) supine position at the end of surgery.
Data Collection:
Preoperative: age, sex, BMI, weight, height, waist and hip circumferences, WHR, ASA classification, comorbidities, baseline hemogram, BUN, creatinine, INR, aPTT, anticoagulant/antiplatelet use.
Intraoperative: surgical procedure type and level, revision status, anesthesia and surgery duration, neuromonitoring use, hemodynamic parameters at standardized time points, estimated blood loss, fluid and blood product administration, vasopressor/inotrope use, urine output, cell saver use.
Postoperative: hemoglobin and hematocrit drop, BUN, creatinine at 24 hours, Aldrete score, VAS score, ICU admission and indication, postoperative complications (surgical and medical), transfusion requirements, and total hospital length of stay.
Statistical Analysis:
SPSS 21.0 will be used. Continuous variables will be reported as mean ± SD or median (IQR) depending on normality (Kolmogorov-Smirnov/Shapiro-Wilk). Categorical variables will be reported as n (%). Between-group comparisons will employ one-way ANOVA or Kruskal-Wallis test for continuous variables and chi-square or Fisher's exact test for categorical variables. Post-hoc pairwise comparisons will be performed with appropriate correction. Significance threshold: p<0.05.
Sample Size:
Based on published BMI-stratified spinal surgery data, a minimum of 90 patients (30 per group) is required to achieve 80% power at α=0.05 (G*Power 3.1).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dilara Göçmen, asst prof
- Número de teléfono: +90 216 625 45 45
- Correo electrónico: dilara.gocmen@marmara.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Seniyye Ülgen Zengin, Assoc Prof
- Correo electrónico: szengin@marmara.edu.tr
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:
- Age 18-80 years
- ASA Physical Status Classification I-III
- Scheduled for elective major lumbar spinal surgery (canal stenosis decompression and/or instrumented fusion)
- No prior lumbar spinal surgery
- Written informed consent obtained
Exclusion Criteria:
- - Pediatric patients (<18 years)
- Pregnancy
- Emergency surgical procedures
- Pre-existing renal failure
- Coagulation disorder
- Pre-existing anemia
- Known drug allergy relevant to study medications
- Inability to obtain written informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group 1 - Non-Obese (NO)
BMI <30 kg/m².
Adult patients undergoing major lumbar spinal surgery without obesity.
Target n=30.
|
Intravesical intraabdominal pressure measurement performed via indwelling urinary catheter at three standardized time points: supine position after intubation, prone position during surgery, and supine position at end of surgery.
This measurement is performed as part of observational data collection within the scope of routine catheterization; no additional invasive procedure is applied.
Standardized TIVA protocol applied uniformly to all patients per institutional neuromonitoring-guided spinal surgery protocol.
Induction with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg; maintenance with propofol and remifentanil infusion.
Adjusted body weight used for drug dosing in obese patients.
No study-specific modification to routine anesthetic management is performed.
Arm Label: All Groups (NO, PO, CO)
|
|
Group 2 - Peripheral Obese (PO)
BMI ≥30 kg/m² and waist-to-hip ratio <0.85.
Patients with predominantly peripheral (gynoid) fat distribution.
Target n=30.
|
Intravesical intraabdominal pressure measurement performed via indwelling urinary catheter at three standardized time points: supine position after intubation, prone position during surgery, and supine position at end of surgery.
This measurement is performed as part of observational data collection within the scope of routine catheterization; no additional invasive procedure is applied.
Standardized TIVA protocol applied uniformly to all patients per institutional neuromonitoring-guided spinal surgery protocol.
Induction with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg; maintenance with propofol and remifentanil infusion.
Adjusted body weight used for drug dosing in obese patients.
No study-specific modification to routine anesthetic management is performed.
Arm Label: All Groups (NO, PO, CO)
|
|
Group 3 - Central Obese (CO)
BMI ≥30 kg/m² and waist-to-hip ratio ≥0.85.
Patients with predominantly central (android) fat distribution.
Target n=30
|
Intravesical intraabdominal pressure measurement performed via indwelling urinary catheter at three standardized time points: supine position after intubation, prone position during surgery, and supine position at end of surgery.
This measurement is performed as part of observational data collection within the scope of routine catheterization; no additional invasive procedure is applied.
Standardized TIVA protocol applied uniformly to all patients per institutional neuromonitoring-guided spinal surgery protocol.
Induction with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg; maintenance with propofol and remifentanil infusion.
Adjusted body weight used for drug dosing in obese patients.
No study-specific modification to routine anesthetic management is performed.
Arm Label: All Groups (NO, PO, CO)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intraoperative Blood Loss
Periodo de tiempo: Intraoperative
|
Total estimated blood loss (mL) calculated from suction canister volume and surgical sponge weight.
|
Intraoperative
|
|
Intraabdominal Pressure (IAP)
Periodo de tiempo: Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery
|
Intravesical IAP measurement (mmHg) via urinary bladder catheter at positional transitions during surgery
|
Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intraoperative Transfusion Requirement
Periodo de tiempo: Intraoperative
|
Number of units of packed red blood cells, fresh frozen plasma, and platelet concentrate administered intraoperatively
|
Intraoperative
|
|
Postoperative Hemoglobin Drop
Periodo de tiempo: Within 24 hours postoperatively
|
Difference between preoperative and postoperative hemoglobin levels (g/dL).
|
Within 24 hours postoperatively
|
|
Vasopressor/Inotrope Requirement
Periodo de tiempo: Intraoperative
|
Type and cumulative dose of vasopressor or inotropic agents administered intraoperatively.
|
Intraoperative
|
|
Postoperative Transfusion Requirement
Periodo de tiempo: up to 7 days postoperatively
|
Postoperative blood product transfusion rate and indication (Hb <7 g/dL, hemodynamic instability, ongoing bleeding).
|
up to 7 days postoperatively
|
|
Postoperative ICU Admission Rate
Periodo de tiempo: postoperative day 1
|
Proportion of patients requiring ICU admission and primary indication (hemodynamic instability, respiratory failure, excessive bleeding, neurological complication).
|
postoperative day 1
|
|
Postoperative Surgical Complications
Periodo de tiempo: Up to 30 days postoperatively
|
Wound infection, deep infection, seroma/hematoma, CSF fistula, neurological deficit, revision surgery requirement
|
Up to 30 days postoperatively
|
|
Postoperative Medical Complications
Periodo de tiempo: Up to 30 days postoperatively
|
Acute kidney injury, deep vein thrombosis, pulmonary embolism, pneumonia, atelectasis, cardiac events, delirium, urinary tract infection.
|
Up to 30 days postoperatively
|
|
Hospital Length of Stay
Periodo de tiempo: From surgery to hospital discharge, assessed up to 30 days
|
Total duration of hospital stay in days(up to 30 days postoperatively),
|
From surgery to hospital discharge, assessed up to 30 days
|
|
Acute Kidney Injury Incidence
Periodo de tiempo: Time Frame: Within 24 hours postoperatively
|
Presence of acute kidney injury assessed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
|
Time Frame: Within 24 hours postoperatively
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
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
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades Musculares
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Enfermedades de la columna
- Exceso de peso
- Síndromes Compartimentales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Estenosis espinal
- Hipertensión intraabdominal
Otros números de identificación del estudio
- mu anesth
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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