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The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine

NCT ID: NCT02127008

Last Updated: 2015-11-20

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

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue. Anatomic studies on posterior epidural space and its contents are few, including semifluid property. In other words, there has not been studied thoroughly regarding the significance and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were free under this layer. The anterior surface of this membrane lay close to the dura mater without any attachment.

To date, the epidural fat has been resected routinely by pituitary forcep and suction drainage during posterior lumbar surgery. However, the investigators focused on the role of epidural fat, which might be associated with postoperative outcome. The investigators thought that this peculiar character, epidural fat, should be caused by certain etiologies. In general, each tissue, such as epidural fat, has its inherited features and significance, thereby the epidural fat has also specific role. However, there has not been fully studies regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural fat on the postoperative outcomes such as pain intensity and functional outcomes by whether the epidural fat would be resected or not during posterior decompressive surgery. The investigators hypothesized that the epidural fat would be associated with postoperative pain intensitive, functional outcomes, and complications of the surgery such as failed back surgery syndrome. In this study, new device for resection of epidural fat was not utilized, but just resected with conventional devices such as pituitary forcep.

Detailed Description

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Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Resection of epidural fat

During surgical procedure, epidural fat was resected fully.

Group Type EXPERIMENTAL

Resection of epidural fat

Intervention Type PROCEDURE

During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.

No resection of epidural fat

During surgical procedure, the epidural fat was not resected.

Group Type ACTIVE_COMPARATOR

No resection of epidural fat

Intervention Type PROCEDURE

During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.

Interventions

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Resection of epidural fat

During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.

Intervention Type PROCEDURE

No resection of epidural fat

During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with a lumbar spinal stenosis, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
* patients who underwent one-level posterior decompression
* patients aging between 20 and 80 years
* patients who volunteered for this study with written consent
* patient who were followed-up for one year or more

Exclusion Criteria

* fractures, infection, or tumors in the lumbar spine
* patients with hemorrhagic disorders such as hemophilia and thrombocythemia
* patient with a follow-up period of less than one year
* patients who are not suitable for this study judged by the principal investigator
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin S. Yeom

Seoul National University Bundang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Armed Forces Yangju Hospital

Yangju, Gyounggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EFDSC-001

Identifier Type: -

Identifier Source: org_study_id