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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07688265
Acronym
OBESPINE
Enrollment
90
Registered
2026-07-07
Start date
2026-06-15
Completion date
2027-06-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraabdominal Hypertension, Intraoperative Blood Loss, Lumbar Degenerative Disease, Lumbar Spinal Stenosis, Obesity, Perioperative Complications

Keywords

major spinal surgery, obesity phenotype, intraabdominal pressure, intraoperative blood loss, perioperative hemorrhage

Brief summary

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

OTHERIntraabdominal 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.

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)

Sponsors

Marmara University Pendik Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative Blood LossIntraoperativeTotal estimated blood loss (mL) calculated from suction canister volume and surgical sponge weight.
Intraabdominal Pressure (IAP)Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgeryIntravesical IAP measurement (mmHg) via urinary bladder catheter at positional transitions during surgery

Secondary

MeasureTime frameDescription
Intraoperative Transfusion RequirementIntraoperativeNumber of units of packed red blood cells, fresh frozen plasma, and platelet concentrate administered intraoperatively
Postoperative Hemoglobin DropWithin 24 hours postoperativelyDifference between preoperative and postoperative hemoglobin levels (g/dL).
Vasopressor/Inotrope RequirementIntraoperativeType and cumulative dose of vasopressor or inotropic agents administered intraoperatively.
Postoperative Transfusion Requirementup to 7 days postoperativelyPostoperative blood product transfusion rate and indication (Hb \<7 g/dL, hemodynamic instability, ongoing bleeding).
Postoperative ICU Admission Ratepostoperative day 1Proportion of patients requiring ICU admission and primary indication (hemodynamic instability, respiratory failure, excessive bleeding, neurological complication).
Postoperative Surgical ComplicationsUp to 30 days postoperativelyWound infection, deep infection, seroma/hematoma, CSF fistula, neurological deficit, revision surgery requirement
Postoperative Medical ComplicationsUp to 30 days postoperativelyAcute kidney injury, deep vein thrombosis, pulmonary embolism, pneumonia, atelectasis, cardiac events, delirium, urinary tract infection.
Hospital Length of StayFrom surgery to hospital discharge, assessed up to 30 daysTotal duration of hospital stay in days(up to 30 days postoperatively),
Acute Kidney Injury IncidenceTime Frame: Within 24 hours postoperativelyPresence of acute kidney injury assessed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

Contacts

CONTACTDilara Göçmen, asst prof
dilara.gocmen@marmara.edu.tr+90 216 625 45 45
CONTACTSeniyye Ülgen Zengin, Assoc Prof
szengin@marmara.edu.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026