Pituitary TumorNCT03719781
Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
An observational study of Pituitary Tumor, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pituitary Tumor
- What is being tested?
- standardized minimental testing
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2018to Mar 2019
- How long will I take part?
- 1 Month
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Undergoing elective pituitary tumor removal surgery
Who may be able to join
- ASA I-II patients
- Undergoing elective pituitery tumor removal surgery
Who cannot join
- >II ASA scores
- Using antidepressant agents
- Patient refusal
- Mental diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
Kocaeli, 41350
Cennet Tor Kılıç, +902623038473
About this study
As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.
- Conditions
- Pituitary Tumor
- Being tested
- standardized minimental testing
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized minimental testingDiagnostic test
To diagnose postoperative cognitive dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Group1 | patients undergoing pituitary tumor removal surgery will be tested with standardized minimental testing. Receives: Diagnostic Test: standardized minimental testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimental test score
scores between 0-30
Measured: preoperative 24th hour
minimental test score
scores between 0-30
Measured: postoperative 4th hour
minimental test score
scores between 0-30
Measured: postoperative 24th hour
minimental test score
scores between 0-30
Measured: one month after discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cennet Tor Kılıc, Kocaeli University
- Investigators
- Cennet Tor Kılıç, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719781
- Sponsor's protocol ID
- GOKAEK 2017/153
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
- ClinicalTrials.gov ID
- NCT03719781
- Acronym / sponsor ID
- GOKAEK 2017/153
- Conditions
- Pituitary Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 25 Oct 2018 (actual)
- 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.
As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Diagnostic Test: standardized minimental testingpatients undergoing pituitary tumor removal surgery will be tested with standardized minimental testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Undergoing elective pituitary tumor removal surgery
Key inclusion criteria (2 listed)
- ASA I-II patients
- Undergoing elective pituitery tumor removal surgery
Key exclusion criteria (4 listed)
- >II ASA scores
- Using antidepressant agents
- Patient refusal
- Mental diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized minimental testingTo diagnose postoperative cognitive dysfunction | Diagnostic test | Group1 |
Primary outcome
minimental test score
Time frame: preoperative 24th hour
scores between 0-30
minimental test score
Time frame: postoperative 4th hour
scores between 0-30
minimental test score
Time frame: postoperative 24th hour
scores between 0-30
minimental test score
Time frame: one month after discharged
scores between 0-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Cennet Tor Kılıç principal investigator
Kocaeli University
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 Pituitary Tumor, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 25 Oct 2018. 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 Turkey (Türkiye). 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 Cennet Tor Kılıç (+903038248, cennetmfk34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minimental test score (time frame: preoperative 24th hour). The study lists 4 primary outcomes in all. 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 25 Oct 2018.