Clinical Trial on Thoracic Surgery, Spinal Epidural Hematoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

The study enrolled patients from January 2010 to December 2019, patients who developed PSEH after posterior thoracic surgery and underwent the hematoma evacuation. For each PSEH patients, 2 or 3 controls who did not develop the PSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period were collected. The preoperative and intraoperative factors, blood pressure related factors and radiographic parameters were collected to identify possible risk factors by comparing between two groups.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100191
    - Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Between January 2010 and December 2019, 1612 patients were performed thoracic decompression surgery due to thoracic spinal stenosis (TSS) caused by thoracic disc herniation, ossification of posterior longitudinal ligament and ligamentum flavum with/without posterior instrumentation in our institution. The SSEH group patients were determined by symptom, MRI, intraoperative finding and underwent hematoma evacuation within one weeks of the initial surgery. For the control group, those who did not develop the SSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.

Description

Inclusion Criteria:

Subjects satisfying the following criteria will be considered eligible for enrollment in this study:

Patient is ≥ 18 years and < 80 years of age;
Patient who received thoracic decompression surgery via posterior approach
Patient who diagnosed as symptomatic spinal epidural haematoma and received revision surgery.

Exclusion Criteria:

Thoracic spinal stenosis caused by trauma, tumor, infectious, deformity and other disease;
Symptomatic spinal epidural haematoma happened at cervicothoracic and thoracolumbar junction;
Initial surgeries were performed at other hospital;
Incomplete clinical data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Symptomatic spinal epidural hematoma Group Patients who performed thoracic decompression surgery and developed neurological deficit after surgery due to the symptomatic spinal epidural hematoma were enrolled into case group.
Control group hose who did not develop the symptomatic spinal epidural hematoma, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large local kyphosis angle Time Frame: 6 months	The local kyphosis angle was determined by the measurement of the Cobb angle. Large local kyphosis angle creates a narrow space between the paravertebral muscles and spinal cord, especially in muscles with edema after surgery. Large local kyphosis angle is considered as a risk factor for symptomatic spinal epidural hematoma	6 months
High occupying ratio of cross-sectional area Time Frame: 6 months	Severe compression on spinal epidural venous plexus lead to poor elasticity of the vessel wall and impedance of blood flow. As a result, dilatation of the spinal epidural venous plexus are more often in symptomatic spinal epidural haematoma patients, contributing to the development of haematoma. Therefore, high occupying ratio of cross-sectional area is considered as a risk factors for symptomatic spinal epidural hematoma.	6 months
Cerebrospinal fluid leakage Time Frame: 6 months	Cerebrospinal fluid leakage provides internal pressure for the dura and its own contents, and a small haematoma does not easily induce symptoms. It is the author's hypothesis that if cerebrospinal fluid leakage occurs intraoperatively, internal pressure loss, even in a small hematoma, can cause compression. Therefore, cerebrospinal fluid leakage are considered as a risk factor for symptomatic spinal epidural hematoma	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Actual)

February 19, 2020

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M2020006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will make the clinical study report available for half a year after the publication of the results of the studys

IPD Sharing Time Frame

The IPD will become available for half a year after the publication of the results of the study.

IPD Sharing Access Criteria

The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests

IPD Sharing Supporting Information Type

CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute