Multicenter Clinical Study on Diagnosis and Treatment of... | NCT02571023

Studies
Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

NCT02571023

Sponsor

Hou Lijun

Status

Unknown status

Last Update Posted

Oct 8, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Skull Injury Trauma

Interventions

microscope surgery
neuroendoscope surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 7, 2015

First Posted Date

Oct 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Measure	Description	Time Frame
mortality		1 year
disability rate		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Skull Base Trauma

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All the patients with skull base trauma in inpatient ward.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lijun Hou, MD	Contact	008602181885671		15921509289@163.com

Overall Officials

Name	Affiliation	Role
Lijun Hou, MD	Department of Neurosurgery, Shanghai Changzheng Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Shanghai Changzheng Hospital		Shanghai	Shanghai Municipality	200003	China

Name	Type	Description	Arm Group Labels	Other Names
microscope surgery	Procedure
neuroendoscope surgery	Procedure