Why Still in Neurosurgical Ward After Tumor Craniotomy?
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05288088 |
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Recruitment Status :
Recruiting
First Posted : March 18, 2022
Last Update Posted : August 17, 2022
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Sponsor:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Alexandra Vassilieva, Rigshospitalet, Denmark
| Tracking Information | |||||||||
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| 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 |
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.
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| 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 |
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| 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 |
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| Intervention | Diagnostic Test: No intervention
This is an observational study
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| Study Groups/Cohorts | Tumor craniotomy patients
Patients undergoing elective brain tumor craniotomy
Intervention: Diagnostic Test: No intervention
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| 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 |
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| PRS Account | Rigshospitalet, Denmark | ||||||||
| Verification Date | August 2022 | ||||||||