NCT03719781

Brief 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. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 22, 2018

Last Update Submit

October 24, 2018

Conditions

Pituitary Tumor

Outcome Measures

Primary Outcomes (4)

  • minimental test score

    scores between 0-30

    preoperative 24th hour

  • minimental test score

    scores between 0-30

    postoperative 4th hour

  • minimental test score

    scores between 0-30

    postoperative 24th hour

  • minimental test score

    scores between 0-30

    one month after discharged

Study Arms (1)

Group1

patients undergoing pituitary tumor removal surgery will be tested with standardized minimental testing.

Diagnostic Test: standardized minimental testing

Interventions

standardized minimental testingDIAGNOSTIC_TEST

To diagnose postoperative cognitive dysfunction

Group1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Undergoing elective pituitary tumor removal surgery

You may qualify if:

  • ASA I-II patients
  • Undergoing elective pituitery tumor removal surgery

You may not qualify if:

  • \>II ASA scores
  • Using antidepressant agents
  • Patient refusal
  • Mental diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Cennet Tor Kılıç

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cennet Tor Kılıç

CONTACT

+903038248cennetmfk34@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Resident

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

November 1, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)