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Why Still in Neurosurgical Ward After Tumor Craniotomy?

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ClinicalTrials.gov Identifier: NCT05288088
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Alexandra Vassilieva, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment
Surgery--Complications Brain Tumor Diagnostic Test: No intervention

Detailed Description:
The concept of fast-track surgery and later enhanced recovery after surgery (ERAS) was first imputed in 1990s. Since then, ERAS protocols have been successfully adopted in many surgical fields, often with dramatic benefits for the patients. Length of hospital stay is one of the main questions addressed in many ERAS studies, as it by a simple approach address many of the complications encountered by the patients or the case flow in the perioperative period. Why patients have prolonged hospital stay after surgery has been investigated by Husted et al. in 2011 after hip and knee arthroplasty and P. Munk-Madsen et al. in 2019 after laparoscopic colorectal surgery. Both studies could isolate dominating factors prolonging hospital stay, some of them preventable. Existing length of stay studies on tumor craniotomy patients have focused on specific variables affecting hospital duration, but never explored the true cause of prolonged hospitalization.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.
Actual Study Start Date : June 12, 2022
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Tumor craniotomy patients
Patients undergoing elective brain tumor craniotomy
 Diagnostic Test: No intervention
This is an observational study


Outcome Measures
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Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Patients are followed for a maximum of 6 months. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective tumor craniotomy with the exception of stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy.
Criteria

Inclusion Criteria:

  • Patients scheduled for elective brain tumor craniotomy

Exclusion Criteria:

  • Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05288088


Contacts
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Contact: Martin K Sørensen, Phd +4535457009 martin.kryspin.soerensen.01@regionh.dk
Contact: Alexandra Vassilieva +4535457230 alexandra.vassilieva@regionh.dk

Locations
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Denmark
Department of Neuroanesthesiology, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Alexandra Vassilieva, MD    +4526525373    alexandra.vassilieva@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Martin K Sørensen, PhD Department of Neuroanesthesiology, Rigshospitalet
More Information
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Responsible Party: Alexandra Vassilieva, Medical doctor, PhD-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05288088    
Other Study ID Numbers: NSwardcraniotomy
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases