Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraabdominal Pressure Measurement via Urinary Bladder Catheter, Total Intravenous Anesthesia (TIVA).
- Who it may be relevant to
- Registry conditions: Lumbar Spinal Stenosis, Lumbar Degenerative Disease, Obesity, Intraabdominal Hypertension. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Obesity Phenotype on Intraabdominal Pressure, Intraoperative Bleeding, and Perioperative Complications in Patients Undergoing Major Lumbar Spinal Surgery: A Prospective Observational Study
Overview
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)
Detailed description
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).
Interventions
- Other Intraabdominal Pressure Measurement via Urinary Bladder Catheter
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. - Other Total Intravenous Anesthesia (TIVA)
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)
Primary outcome measures
- Intraoperative Blood Loss [Time frame: Intraoperative]
- Intraabdominal Pressure (IAP) [Time frame: Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery]
Secondary outcome measures (9)
- Intraoperative Transfusion Requirement [Time frame: Intraoperative]
- Postoperative Hemoglobin Drop [Time frame: Within 24 hours postoperatively]
- Vasopressor/Inotrope Requirement [Time frame: Intraoperative]
- Postoperative Transfusion Requirement [Time frame: up to 7 days postoperatively]
- Postoperative ICU Admission Rate [Time frame: postoperative day 1]
- Postoperative Surgical Complications [Time frame: Up to 30 days postoperatively]
- Postoperative Medical Complications [Time frame: Up to 30 days postoperatively]
- Hospital Length of Stay [Time frame: From surgery to hospital discharge, assessed up to 30 days]
- Acute Kidney Injury Incidence [Time frame: Time Frame: Within 24 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07688265 · mu anesth