[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646727":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":10,"centralContacts":32,"locations":10,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":10},{"fullName":5,"class":6},"Marmara University Pendik Training and Research Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Non-Obese (NO)",null,"BMI \\\u003C30 kg\u002Fm². Adult patients undergoing major lumbar spinal surgery without obesity. Target n=30.",[13,14],"Other: Intraabdominal Pressure Measurement via Urinary Bladder Catheter","Other: Total Intravenous Anesthesia (TIVA)",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2 - Peripheral Obese (PO)","BMI ≥30 kg\u002Fm² and waist-to-hip ratio \\\u003C0.85. Patients with predominantly peripheral (gynoid) fat distribution. Target n=30.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3 - Central Obese (CO)","BMI ≥30 kg\u002Fm² and waist-to-hip ratio ≥0.85. Patients with predominantly central (android) fat distribution. Target n=30",[13,14],[24,28],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"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.",[9,16,20],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Total Intravenous Anesthesia (TIVA)","Standardized TIVA protocol applied uniformly to all patients per institutional neuromonitoring-guided spinal surgery protocol. Induction with propofol 2 mg\u002Fkg, fentanyl 2 µg\u002Fkg, and rocuronium 0.6 mg\u002Fkg; 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)",[9,16,20],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Dilara Göçmen, asst prof","CONTACT","+90 216 625 45 45","dilara.gocmen@marmara.edu.tr",{"name":39,"role":35,"phone":10,"phoneExt":10,"email":40},"Seniyye Ülgen Zengin, Assoc Prof","szengin@marmara.edu.tr",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100646727","effect-of-obesity-phenotype-on-intraabdominal-pressure-and-bleeding-in-major-lumbar-spinal-surgery-100646727",false,"NCT07688265","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","OBESPINE","Inclusion Criteria:\n\n* Age 18-80 years\n* ASA Physical Status Classification I-III\n* Scheduled for elective major lumbar spinal surgery (canal stenosis decompression and\u002For instrumented fusion)\n* No prior lumbar spinal surgery\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* \\- Pediatric patients (\\\u003C18 years)\n* Pregnancy\n* Emergency surgical procedures\n* Pre-existing renal failure\n* Coagulation disorder\n* Pre-existing anemia\n* Known drug allergy relevant to study medications\n* Inability to obtain written informed consent","ALL","18 Years","80 Years",{"count":55,"type":56},90,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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\u002For instrumentation)",[60,61,62,63,64,65],"Lumbar Spinal Stenosis","Lumbar Degenerative Disease","Obesity","Intraabdominal Hypertension","Intraoperative Blood Loss","Perioperative Complications",[67,68,69,70,71],"major spinal surgery","obesity phenotype","intraabdominal pressure","intraoperative blood loss","perioperative hemorrhage","NOT_YET_RECRUITING","2026-07-05",{"date":75,"type":76},"2026-07-07","ACTUAL",{"date":78,"type":56},"2026-06-15",{"date":80,"type":56},"2027-06-01",{"name":5,"class":6}]