- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07688265
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)
Przegląd badań
Status
Warunki
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Dilara Göçmen, asst prof
- Numer telefonu: +90 216 625 45 45
- E-mail: dilara.gocmen@marmara.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: Seniyye Ülgen Zengin, Assoc Prof
- E-mail: szengin@marmara.edu.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intraoperative Blood Loss
Ramy czasowe: Intraoperative
|
Total estimated blood loss (mL) calculated from suction canister volume and surgical sponge weight.
|
Intraoperative
|
|
Intraabdominal Pressure (IAP)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intraoperative Transfusion Requirement
Ramy czasowe: Intraoperative
|
Number of units of packed red blood cells, fresh frozen plasma, and platelet concentrate administered intraoperatively
|
Intraoperative
|
|
Postoperative Hemoglobin Drop
Ramy czasowe: Within 24 hours postoperatively
|
Difference between preoperative and postoperative hemoglobin levels (g/dL).
|
Within 24 hours postoperatively
|
|
Vasopressor/Inotrope Requirement
Ramy czasowe: Intraoperative
|
Type and cumulative dose of vasopressor or inotropic agents administered intraoperatively.
|
Intraoperative
|
|
Postoperative Transfusion Requirement
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby kości
- Choroby układu mięśniowo-szkieletowego
- Choroby naczyniowe
- Choroby układu krążenia
- Choroby mięśni
- Zaburzenia odżywiania
- Przekarmienie
- Masy ciała
- Choroby kręgosłupa
- Nadwaga
- Syndromy przedziałowe
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Otyłość
- Zwężenie kręgosłupa
- Nadciśnienie wewnątrzbrzuszne
Inne numery identyfikacyjne badania
- mu anesth
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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