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

Not Applicable

Completed

• Conditions: Drain Tube Influence the Postoperative Epidural Haematoma
• Interventions: Procedure: two level lumbar decompression with BESS procedure received one drain.; Procedure: two level lumbar decompression with BESS procedure received two drain.

• Registration Number: NCT06290791
• Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-31
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Study Completion: 2024-02-10
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A (with one drain)	two level lumbar decompression with BESS procedure received one drain.	-
the group B (with two drains)	two level lumbar decompression with BESS procedure received two drain.	-

Primary Outcome Measures

Name	Time	Method
the cross-sectional area of POSEH	24 hours after drain withdrawal	the cross-sectional area of the 72th-hour POSEH after surgery

Secondary Outcome Measures

Name	Time	Method
the volume of drain output	48 hours after surgery	the total volume of the drain or drains

Trial Locations

Locations (1)

Zhonglin Zhong; 🇨🇳 Yiwu, Zhejiang, China