Why Still in Neurosurgical Ward After Tumor Craniotomy?

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05288088
Collaborator
(none)
200
1
30.7
6.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Jun 12, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Tumor craniotomy patients

Patients undergoing elective brain tumor craniotomy

Diagnostic Test: No intervention
This is an observational study

Outcome Measures

Primary Outcome Measures

  1. Hospital length of stay [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients scheduled for elective brain tumor craniotomy
Exclusion Criteria:
  • Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neuroanesthesiology, Rigshospitalet Copenhagen Denmark

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandra Vassilieva, Medical doctor, PhD-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05288088
Other Study ID Numbers:
  • NSwardcraniotomy
First Posted:
Mar 18, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022