Why Still in Neurosurgical Ward After Tumor Craniotomy?

November 15, 2023 updated by: Alexandra Vassilieva, Rigshospitalet, Denmark

Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Neuroanesthesiology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

Inclusion Criteria:

  • Patients scheduled for elective brain tumor craniotomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tumor craniotomy patients
Patients undergoing elective brain tumor craniotomy
Diagnostic test: No intervention
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients are followed for a maximum of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Martin K Sørensen, PhD, Department of Neuroanesthesiology, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2022

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSwardcraniotomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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