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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2024-02-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Drain Tube Influence the Postoperative Epidural Haematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group A (with one drain)

Group Type EXPERIMENTAL

two level lumbar decompression with BESS procedure received one drain.

Intervention Type PROCEDURE

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

the group B (with two drains)

Group Type ACTIVE_COMPARATOR

two level lumbar decompression with BESS procedure received two drain.

Intervention Type PROCEDURE

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

Interventions

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two level lumbar decompression with BESS procedure received one drain.

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

Intervention Type PROCEDURE

two level lumbar decompression with BESS procedure received two drain.

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No