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OpenTrials
Completed

NCT Number: NCT06290791

Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery?

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.

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Key information

Conditions

Drain Tube Influence the Postoperative Epidural Haematoma Bone Diseases Hematoma Hematoma, Epidural, Spinal Hemorrhage Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhonglin Zhong

Yiwu, Zhejiang, 322000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.

Treatment and study plan

two level lumbar decompression with BESS procedure received one drain.

Procedure

patients who underwent two level lumbar decompression with BESS procedure received one drain.

two level lumbar decompression with BESS procedure received two drain.

Procedure

patients who underwent two level lumbar decompression with BESS procedure received two drains

Primary outcomes

  1. the cross-sectional area of POSEH

    Time frame: 24 hours after drain withdrawal

    the cross-sectional area of the 72th-hour POSEH after surgery

Secondary outcomes

  1. the volume of drain output

    Time frame: 48 hours after surgery

    the total volume of the drain or drains

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? A Randomized, Controlled Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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