Why Still in Neurosurgical Ward After Tumor Craniotomy?

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients scheduled for elective brain tumor craniotomy.

Exclusion Criteria:

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05288088
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rigshospitalet, Denmark
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Martin K Sørensen, PhD
Principal Investigator Affiliation	Department of Neuroanesthesiology, Rigshospitalet
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Surgery--Complications, Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

: Tumor craniotomy patients

Patients undergoing elective brain tumor craniotomy

Interventions

Diagnostic Test: - No intervention

This is an observational study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Copenhagen, Denmark

Status

Recruiting

Address

Department of Neuroanesthesiology, Rigshospitalet

Copenhagen, ,

Site Contact

Alexandra Vassilieva, MD

alexandra.vassilieva@regionh.dk

+4526525373

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