NCT01806155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

March 3, 2013

Last Update Submit

August 16, 2013

Conditions

Adult Brain TumorHeadache

Keywords

craniotomyheadachepostoperative

Outcome Measures

Primary Outcomes (1)

  • The incidence of headache after major craniotomy

    By asking the patients about the symptoms

    3 months

Secondary Outcomes (1)

  • risk factors of headache after major craniotomy such as sex, education

    3 months

Study Arms (1)

Craniotomy

Patient undergoing major craniotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing major craniotomy

You may qualify if:

  • Patient undergoing major craniotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsHeadache

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sirilak Suksompong, MD

CONTACT

6624113256sirilak.suk@mahidol.ac.th

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2013

First Posted

March 7, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

October 1, 2014

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

TH(1)