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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

Tracking Information
First Submitted Date February 24, 2022
First Posted Date March 18, 2022
Last Update Posted Date August 17, 2022
Actual Study Start Date June 12, 2022
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2022)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Why Still in Neurosurgical Ward After Tumor Craniotomy?
Official Title Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Surgery--Complications
  • Brain Tumor
Intervention Diagnostic Test: No intervention
This is an observational study
Study Groups/Cohorts Tumor craniotomy patients
Patients undergoing elective brain tumor craniotomy
Intervention: Diagnostic Test: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 15, 2022)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients scheduled for elective brain tumor craniotomy

Exclusion Criteria:

  • Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Martin K Sørensen, Phd +4535457009 martin.kryspin.soerensen.01@regionh.dk
Contact: Alexandra Vassilieva +4535457230 alexandra.vassilieva@regionh.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT05288088
Other Study ID Numbers NSwardcraniotomy
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Alexandra Vassilieva, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor Rigshospitalet, Denmark
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Martin K Sørensen, PhD Department of Neuroanesthesiology, Rigshospitalet
PRS Account Rigshospitalet, Denmark
Verification Date August 2022