Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

October 7, 2015 updated by: Hou Lijun

The purposes of this study are as follows:

to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity.
to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma.
to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.
to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.

Study Overview

Status

Unknown

Conditions

Skull Injury Trauma

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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
- Shanghai
  - Shanghai, Shanghai, China, 200003
    - Department of Neurosurgery, Shanghai Changzheng 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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients with skull base trauma in inpatient ward.

Description

Inclusion Criteria:

Clinical diagnosis of Skull Base Trauma

Exclusion Criteria:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality Time Frame: 1 year	1 year
disability rate Time Frame: 1 year	1 year

Collaborators and Investigators

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

Sponsor

Hou Lijun

Investigators

Study Chair: Lijun Hou, MD, Department of Neurosurgery, Shanghai Changzheng Hospital

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

January 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Estimate)