HealthyNCT00785096
How do Patients, Nurses and Physicians Perceive Negative Postoperative Events?
An observational study of Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Questionnaire
- How many people
- 615 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Dec 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will admit for a minor or major surgical procedure Nurses from the University Hospital of Zurich Different physicians of the University Hospital of Zurich (surgeons, anesthesia, urologist ans ICU-care specialists)and other institutions.
Who may be able to join
- Age: ≥ 18 years
- Capacity to act and no legal guardian
- Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
- German language as daily language.
Who cannot join
- Patients with cognitive difficulties and diseases, which may yield unreliable answers
- Patients unable to read and write
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Perception of Surgical Complications - Agreements Among Patients, Nurses and Physicians
The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures.
- Conditions
- Healthy
- Being tested
- Questionnaire
- Keywords
- Perception, surgical complications, patients, nurses and physicians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire, complications, grading severity, visual analog scale
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who admit for a minor or major surgical intervention Receives: Other: Questionnaire | |
| Nurses | Medical staff of the University Hospital of Zurich Receives: Other: Questionnaire | |
| Physicians | Medical staff of the University Hospital of Zurich and other institutions Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess how patients, nurses and physicians perceive negative events following surgical procedures
Measured: August 2008- December 2009
Secondary outcomes (1)
Association to the Clavien Dindo Classification
Measured: August 2008 - December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ksenija Slankamenac, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785096
- Sponsor's protocol ID
- 30-2008
- Status last verified
- Feb 2015
- First submitted
- 4 Nov 2008
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Surgical Complications - Agreements Among Patients, Nurses and Physicians
- ClinicalTrials.gov ID
- NCT00785096
- Acronym / sponsor ID
- 30-2008
- Conditions
- Healthy
- Keywords
- Perception, surgical complications, patients, nurses and physicians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Nov 2008 (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.
The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairePatients who admit for a minor or major surgical intervention |
| Nurses | – | Other: QuestionnaireMedical staff of the University Hospital of Zurich |
| Physicians | – | Other: QuestionnaireMedical staff of the University Hospital of Zurich and other institutions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will admit for a minor or major surgical procedure Nurses from the University Hospital of Zurich Different physicians of the University Hospital of Zurich (surgeons, anesthesia, urologist ans ICU-care specialists)and other institutions.
Key inclusion criteria (4 listed)
- Age: ≥ 18 years
- Capacity to act and no legal guardian
- Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
- German language as daily language.
Key exclusion criteria (2 listed)
- Patients with cognitive difficulties and diseases, which may yield unreliable answers
- Patients unable to read and write
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 |
|---|---|---|
| QuestionnaireQuestionnaire, complications, grading severity, visual analog scale | Other | Nurses, Patients, Physicians |
Primary outcome
To assess how patients, nurses and physicians perceive negative events following surgical procedures
Time frame: August 2008- December 2009
1 secondary outcome
Association to the Clavien Dindo Classification
Time frame: August 2008 - December 2009
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 10 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 2 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 10 Feb 2015. 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 Switzerland. 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?
To assess how patients, nurses and physicians perceive negative events following surgical procedures (time frame: August 2008- December 2009). 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 10 Feb 2015.