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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

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

De observación

Inscripción (Estimado)

90

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

Adult patients aged 18-80 years with ASA physical status I-III scheduled for elective major lumbar spinal surgery (decompression and/or instrumentation) at Marmara University Pendik Training and Research Hospital and Asaf Ataseven Hospital, Istanbul, Turkey. Patients are classified by obesity phenotype based on BMI and waist-to-hip ratio. Patients with renal failure, coagulation disorders, anemia, pregnancy, prior lumbar surgery, or emergency procedures are excluded.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de junio de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2026

Publicado por primera vez (Actual)

7 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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