NCT05288088

Brief Summary

The aim of this prospective observational study is to identify the specific reasons that prolong a hospital stay after elective tumor craniotomy. Optimal postoperative in-hospital stay is considered to be two days from surgery to discharge from the neurosurgical ward. However, a variable length of stay at a neurological department for follow-up of late recognized deficits of neurological consequences of the surgical procedure are common.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

February 24, 2022

Last Update Submit

November 15, 2023

Conditions

Surgery--ComplicationsBrain Tumor

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Length of stay is defined as the length of inpatient stay, based on number of nights spent at the neurosurgical ward, calculated from the day of surgery to the day of discharge from the neurosurgical ward.

    Patients are followed for a maximum of 6 months.

Study Arms (1)

Tumor craniotomy patients

Patients undergoing elective brain tumor craniotomy

Diagnostic Test: No intervention

Interventions

No interventionDIAGNOSTIC_TEST

This is an observational study

Tumor craniotomy patients

Eligibility Criteria

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

Patients scheduled for elective tumor craniotomy with the exception of stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy.

You may qualify if:

  • Patients scheduled for elective brain tumor craniotomy

You may not qualify if:

  • Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroanesthesiology, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Martin K Sørensen, PhD

    Department of Neuroanesthesiology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, PhD-student

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 18, 2022

Study Start

June 12, 2022

Primary Completion

June 28, 2023

Study Completion

November 15, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

DK(1)