Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery (NCT07688265) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery
90 participantsStarted 2026-06-15
Plain-language 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)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Blood Loss
Timeframe: Intraoperative
2
Intraabdominal Pressure (IAP)
Timeframe: Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery
Trial details
NCT IDNCT07688265
SponsorMarmara University Pendik Training and Research Hospital