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NCT Number: NCT07688265

Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery

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)

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraabdominal Pressure Measurement via Urinary Bladder Catheter

Other

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.

Total Intravenous Anesthesia (TIVA)

Other

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 outcomes

  1. Intraoperative Blood Loss

    Time frame: Intraoperative

    Total estimated blood loss (mL) calculated from suction canister volume and surgical sponge weight.

  2. 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

    Intravesical IAP measurement (mmHg) via urinary bladder catheter at positional transitions during surgery

Secondary outcomes

  1. Intraoperative Transfusion Requirement

    Time frame: Intraoperative

    Number of units of packed red blood cells, fresh frozen plasma, and platelet concentrate administered intraoperatively

  2. Postoperative Hemoglobin Drop

    Time frame: Within 24 hours postoperatively

    Difference between preoperative and postoperative hemoglobin levels (g/dL).

  3. Vasopressor/Inotrope Requirement

    Time frame: Intraoperative

    Type and cumulative dose of vasopressor or inotropic agents administered intraoperatively.

  4. Postoperative Transfusion Requirement

    Time frame: up to 7 days postoperatively

    Postoperative blood product transfusion rate and indication (Hb <7 g/dL, hemodynamic instability, ongoing bleeding).

  5. Postoperative ICU Admission Rate

    Time frame: postoperative day 1

    Proportion of patients requiring ICU admission and primary indication (hemodynamic instability, respiratory failure, excessive bleeding, neurological complication).

  6. Postoperative Surgical Complications

    Time frame: Up to 30 days postoperatively

    Wound infection, deep infection, seroma/hematoma, CSF fistula, neurological deficit, revision surgery requirement

  7. Postoperative Medical Complications

    Time frame: Up to 30 days postoperatively

    Acute kidney injury, deep vein thrombosis, pulmonary embolism, pneumonia, atelectasis, cardiac events, delirium, urinary tract infection.

  8. Hospital Length of Stay

    Time frame: From surgery to hospital discharge, assessed up to 30 days

    Total duration of hospital stay in days(up to 30 days postoperatively),

  9. Acute Kidney Injury Incidence

    Time frame: Time Frame: Within 24 hours postoperatively

    Presence of acute kidney injury assessed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Göçmen, asst prof

CONTACT

[email protected]

+90 216 625 45 45

Seniyye Ülgen Zengin, Assoc Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

Effect of Obesity Phenotype on Intraabdominal Pressure, Intraoperative Bleeding, and Perioperative Complications in Patients Undergoing Major Lumbar Spinal Surgery: A Prospective Observational Study

Acronym: OBESPINE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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