An interventional study of two level lumbar decompression with BESS procedure received one drain. and two level lumbar decompression with BESS procedure received two drain. in Drain Tube Influence the Postoperative Epidural Haematoma, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Completed at 1 site in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Prevention
The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.
How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.
20 studies on the registry are indexed under Hematoma, Epidural, Spinal; 5 are open to participants now.
This study's enrollment of 89 is below the median of 151 across 11 interventional studies indexed under Hematoma, Epidural, Spinal.
Browse Hematoma, Epidural, Spinal studies →The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 92 studies on the registry; 78 are open to participants now.
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All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.
Exclusion Criteria:
Patients were excluded if radiography revealed lumbar instability (motion of >3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had (ASA) class Ⅳ or severe systemic disease.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: two level lumbar decompression with BESS procedure received one drain.
Procedure: two level lumbar decompression with BESS procedure received two drain.
patients who underwent two level lumbar decompression with BESS procedure received one drain.
patients who underwent two level lumbar decompression with BESS procedure received two drains
the cross-sectional area of POSEH
the cross-sectional area of the 72th-hour POSEH after surgery
Time frame: 24 hours after drain withdrawal
the volume of drain output
the total volume of the drain or drains
Time frame: 48 hours after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Dec 2023, 36 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine