Surgery--ComplicationsNCT05288088
Why Still in Neurosurgical Ward After Tumor Craniotomy?
An observational study of Surgery--Complications and Brain Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Brain Tumor
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jun 2022to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective tumor craniotomy with the exception of stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy.
Who may be able to join
- Patients scheduled for elective brain tumor craniotomy
Who cannot join
- Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery--Complications, Brain Tumor
- Being tested
- No intervention
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Tumor craniotomy patients | Patients undergoing elective brain tumor craniotomy Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
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.
Measured: Patients are followed for a maximum of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start12 Jun 2022
- Primary completion28 Jun 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Vassilieva, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Martin K Sørensen, PhD, Principal investigator, Department of Neuroanesthesiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288088
- Sponsor's protocol ID
- NSwardcraniotomy
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.
- ClinicalTrials.gov ID
- NCT05288088
- Acronym / sponsor ID
- NSwardcraniotomy
- Conditions
- Surgery--Complications, Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor craniotomy patients | – | Diagnostic Test: No interventionPatients undergoing elective brain tumor craniotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective tumor craniotomy with the exception of stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy.
Key inclusion criteria (1 listed)
- Patients scheduled for elective brain tumor craniotomy
Key exclusion criteria (1 listed)
- Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Diagnostic test | Tumor craniotomy patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Surgery--Complications
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin K Sørensen, PhD principal investigator
Department of Neuroanesthesiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Brain Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Patients are followed for a maximum of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.