NCT04961424|Completed
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Sponsor study identifier
observational
22
1 country
1
Study Start
February 19, 2020
Actual (reported)Primary Completion
February 19, 2020
Actual (reported)Study Completion
February 18, 2021
Actual (reported)This is a retrospective, observational single-center study. The studies is to investigate the incidence of posterior epidural spinal hematoma(PSEH) and recognize the risk factors for it in a cohort of patients undergoing posterior thoracic surgery in isolation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 18, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2020
Actual (reported)February 19, 2020
Actual (reported)February 18, 2021
Actual (reported)June 27, 2021
Actual (reported)July 14, 2021
Actual (reported)Large local kyphosis angle
The local kyphosis angle was determined by the measurement of the Cobb angle. Large local kyphosis angle creates a narrow space between the paravertebral muscles and spinal cord, especially in muscles with edema after surgery. Large local kyphosis angle is considered as a risk factor for symptomatic spinal epidural hematoma
6 months
High occupying ratio of cross-sectional area
Severe compression on spinal epidural venous plexus lead to poor elasticity of the vessel wall and impedance of blood flow. As a result, dilatation of the spinal epidural venous plexus are more often in symptomatic spinal epidural haematoma patients, contributing to the development of haematoma. Therefore, high occupying ratio of cross-sectional area is considered as a risk factors for symptomatic spinal epidural hematoma.
6 months
Cerebrospinal fluid leakage
Cerebrospinal fluid leakage provides internal pressure for the dura and its own contents, and a small haematoma does not easily induce symptoms. It is the author's hypothesis that if cerebrospinal fluid leakage occurs intraoperatively, internal pressure loss, even in a small hematoma, can cause compression. Therefore, cerebrospinal fluid leakage are considered as a risk factor for symptomatic spinal epidural hematoma
Patients who performed thoracic decompression surgery and developed neurological deficit after surgery due to the symptomatic spinal epidural hematoma were enrolled into case group.
hose who did not develop the symptomatic spinal epidural hematoma, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.
Between January 2010 and December 2019, 1612 patients were performed thoracic decompression surgery due to thoracic spinal stenosis (TSS) caused by thoracic disc herniation, ossification of posterior longitudinal ligament and ligamentum flavum with/without posterior instrumentation in our institution. The SSEH group patients were determined by symptom, MRI, intraoperative finding and underwent hematoma evacuation within one weeks of the initial surgery. For the control group, those who did not develop the SSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.
Peking University Third hospital
Beijing, Beijing Municipality, 100191, China
Leonardi MA, Zanetti M, Saupe N, Min K. Early postoperative MRI in detecting hematoma and dural compression after lumbar spinal decompression: prospective study of asymptomatic patients in comparison to patients requiring surgical revision. Eur Spine J. 2010 Dec;19(12):2216-22. doi: 10.1007/s00586-010-1483-x. Epub 2010 Jun 17.
Amiri AR, Fouyas IP, Cro S, Casey AT. Postoperative spinal epidural hematoma (SEH): incidence, risk factors, onset, and management. Spine J. 2013 Feb;13(2):134-40. doi: 10.1016/j.spinee.2012.10.028. Epub 2012 Dec 5.
Weishi Li, M.D.
Peking University Third Hospital
22 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2021
First Posted
July 14, 2021
Study Start
February 19, 2020
Actual (reported)The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation
6 months
Contact the study team to confirm eligibility.
Delamarter RB, Sherman J, Carr JB. Pathophysiology of spinal cord injury. Recovery after immediate and delayed decompression. J Bone Joint Surg Am. 1995 Jul;77(7):1042-9. doi: 10.2106/00004623-199507000-00010.
Yamada K, Abe Y, Satoh S, Yanagibashi Y, Hyakumachi T, Masuda T. Large Increase in Blood Pressure After Extubation and High Body Mass Index Elevate the Risk of Spinal Epidural Hematoma After Spinal Surgery. Spine (Phila Pa 1976). 2015 Jul 1;40(13):1046-52. doi: 10.1097/BRS.0000000000000876.
Fujiwara Y, Manabe H, Izumi B, Harada T, Nakanishi K, Tanaka N, Adachi N. The impact of hypertension on the occurrence of postoperative spinal epidural hematoma following single level microscopic posterior lumbar decompression surgery in a single institute. Eur Spine J. 2017 Oct;26(10):2606-2615. doi: 10.1007/s00586-017-5165-9. Epub 2017 Jun 9.
Kao FC, Tsai TT, Chen LH, Lai PL, Fu TS, Niu CC, Ho NY, Chen WJ, Chang CJ. Symptomatic epidural hematoma after lumbar decompression surgery. Eur Spine J. 2015 Feb;24(2):348-57. doi: 10.1007/s00586-014-3297-8. Epub 2014 Apr 24.
Fujita N, Michikawa T, Yagi M, Suzuki S, Tsuji O, Nagoshi N, Okada E, Tsuji T, Nakamura M, Matsumoto M, Watanabe K. Impact of lumbar hypolordosis on the incidence of symptomatic postoperative spinal epidural hematoma after decompression surgery for lumbar spinal canal stenosis. Eur Spine J. 2019 Jan;28(1):87-93. doi: 10.1007/s00586-018-5782-y. Epub 2018 Oct 9.
Knusel K, Du JY, Ren B, Kim CY, Ahn UM, Ahn NU. Symptomatic Epidural Hematoma after Elective Posterior Lumbar Decompression: Incidence, Timing, Risk Factors, and Associated Complications. HSS J. 2020 Dec;16(Suppl 2):230-237. doi: 10.1007/s11420-019-09690-2. Epub 2019 Jul 1.
Hohenberger C, Zeman F, Hohne J, Ullrich OW, Brawanski A, Schebesch KM. Symptomatic Postoperative Spinal Epidural Hematoma after Spinal Decompression Surgery: Prevalence, Risk Factors, and Functional Outcome. J Neurol Surg A Cent Eur Neurosurg. 2020 Jul;81(4):290-296. doi: 10.1055/s-0039-1697024. Epub 2020 Jan 14.
Mueller K, Altshuler M, Voyadzis JM, Sandhu FA. The incidence of symptomatic postoperative epidural hematoma after minimally invasive lumbar decompression: A single institution retrospective review. Clin Neurol Neurosurg. 2020 Aug;195:105868. doi: 10.1016/j.clineuro.2020.105868. Epub 2020 Apr 22.
Primary Completion
February 19, 2020
Actual (reported)Study Completion
February 18, 2021
Actual (reported)Last Updated
July 14, 2021
Record last verified: 2021-07
We will make the clinical study report available for half a year after the publication of the results of the studys
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