Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty PatientsNCT02576405
Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty
An observational study of Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Danish population sample (N=2000) of hip and knee arthroplasty patients in an elective fast-track setting.
Who may be able to join
- All patients planned for elective unilateral fast-track hip or knee arthroplasty.
- Age > 18.
- Can understand and read danish.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characterization of Preoperative Psychiatric Disorder in Relation to Postoperative Morbidity in Elective Fast-Track Total Hip and Knee Arthroplasty
It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.
Recent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire
Measured: 90 days postoperatively
Secondary outcomes (2)
Length of stay
Measured: 90 days postoperatively
Readmissions
Measured: 30 and 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty PatientsStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silas Hinsch Gylvin, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576405
- Sponsor's protocol ID
- SG
- Status last verified
- Sep 2015
- First submitted
- 13 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Preoperative Psychiatric Disorder in Relation to Postoperative Morbidity in Elective Fast-Track Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02576405
- Acronym / sponsor ID
- SG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Oct 2015 (estimated)
- 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.
It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.
Recent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Danish population sample (N=2000) of hip and knee arthroplasty patients in an elective fast-track setting.
Key inclusion criteria (3 listed)
- All patients planned for elective unilateral fast-track hip or knee arthroplasty.
- Age > 18.
- Can understand and read danish.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire
Time frame: 90 days postoperatively
2 secondary outcomes
Length of stay
Time frame: 90 days postoperatively
Readmissions
Time frame: 30 and 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients, run by Copenhagen University Hospital, Rigshospitalet.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silas Gylvin, MD (+45 51 29 68 05, silasgylvin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire (time frame: 90 days postoperatively). 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 15 Oct 2015.