Prevalence of Post-craniotomy Headache in Siriraj Hospital | NCT01806155

Studies
Prevalence of Post-craniotomy Headache in Siriraj Hospital

NCT01806155

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Aug 19, 2013Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Adult Brain Tumor
Headache

Interventions

Not provided

Countries

Thailand

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Mar 3, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 7, 2013Estimated

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

Aug 16, 2013

Last Update Posted Date

Aug 19, 2013Estimated

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

Headache after major craniotomy may be a problem in taking care of the patients. The investigators want to identify the incidence of headache after major craniotomy and also the risk factors.

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

200Estimated

Label	Type	Description	Intervention Names
Craniotomy		Patient undergoing major craniotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of headache after major craniotomy	By asking the patients about the symptoms	3 months

Secondary Outcomes

Measure	Description	Time Frame
risk factors of headache after major craniotomy such as sex, education	by collecting the patients data	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing major craniotomy

Exclusion Criteria:

emergency surgery or traumatic patients
may need postoperative ventilatory support more than 2 days
cannot communicate
psychiatric patients
chronic use of benzodiazepine or drug abuse
cannot follow the treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient undergoing major craniotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sirilak Suksompong, MD	Contact	6624113256		sirilak.suk@mahidol.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Siriraj Hospital, Mahidol University	Recruiting	Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D006261	Headache

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided