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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMarmara University Pendik Training and Research Hospital

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- Pediatric patients (<18 years)

Pregnancy

Emergency surgical procedures

Pre-existing renal failure

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraabdominal Pressure Measurement via Urinary Bladder Catheter

    Other intervention

    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 intervention

    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)

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group 1 - Non-Obese (NO)2 interventions
Group B: Group 2 - Peripheral Obese (PO)2 interventions
Group C: Group 3 - Central Obese (CO)2 interventions

Trial outcomes

Primary outcomes

1

Intraoperative Blood Loss

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

Time frame
Intraoperative
2

Intraabdominal Pressure (IAP)

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

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 outcomes

1

Intraoperative Transfusion Requirement

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

Time frame
Intraoperative
2

Postoperative Hemoglobin Drop

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

Time frame
Within 24 hours postoperatively
3

Vasopressor/Inotrope Requirement

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

Time frame
Intraoperative
4

Postoperative Transfusion Requirement

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

Time frame
up to 7 days postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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