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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Completed

Conditions: Drain Tube Influence the Postoperative Epidural Haematoma

Treatments: Procedure: two level lumbar decompression with BESS procedure received two drain.; Procedure: two level lumbar decompression with BESS procedure received one drain.

Study type: Interventional

Funder types: Other

Identifiers

NCT06290791

K2020214

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups

group A (with one drain)

Experimental group

Treatment:

Procedure: two level lumbar decompression with BESS procedure received one drain.

the group B (with two drains)

Active Comparator group

Treatment:

Procedure: two level lumbar decompression with BESS procedure received two drain.