Adult Brain TumorNCT01806155
Prevalence of Post-craniotomy Headache in Siriraj Hospital
An observational study of Adult Brain Tumor and Headache, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Brain Tumor, Headache
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing major craniotomy
Who may be able to join
- Patient undergoing major craniotomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Sirilak Suksompong, MD, 6624113256, sirilak.suk@mahidol.ac.th
About this study
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.
- Conditions
- Adult Brain Tumor, Headache
- Keywords
- craniotomy, headache, postoperative
- Medical subject headings
- Brain Neoplasms, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Craniotomy | Patient undergoing major craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of headache after major craniotomy
By asking the patients about the symptoms
Measured: 3 months
Secondary outcomes (1)
risk factors of headache after major craniotomy such as sex, education
by collecting the patients data
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Brain TumorStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806155
- Sponsor's protocol ID
- 734/2555(EC2)
- Status last verified
- Aug 2013
- First submitted
- 3 Mar 2013
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Post-craniotomy Headache in Siriraj Hospital
- ClinicalTrials.gov ID
- NCT01806155
- Acronym / sponsor ID
- 734/2555(EC2)
- Conditions
- Adult Brain Tumor, Headache
- Keywords
- craniotomy, headache, postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Craniotomy | – | –Patient undergoing major craniotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing major craniotomy
Key inclusion criteria (1 listed)
- Patient undergoing major craniotomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of headache after major craniotomy
Time frame: 3 months
By asking the patients about the symptoms
1 secondary outcome
risk factors of headache after major craniotomy such as sex, education
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Brain Tumor and Headache, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirilak Suksompong, MD (6624113256, sirilak.suk@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of headache after major craniotomy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2013.