Surgical Behaviour in the Operating RoomNCT01334411
Identifying Good and Poor Surgical Behaviour in the Danish Operating Room
An observational study of Surgical Behaviour in the Operating Room, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery. Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Behaviour in the Operating Room
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Mar 2011
- 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
- Child, Adult, Older adult
Study population: The interview informants are health care personell in two Danish Hospitals as described in the project description
Who may be able to join
- medical professionals at Rigshospitalet and Herlev Hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery.
Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with empirical background knowledge of observed surgical behaviour as well as an understanding of surgical culture. The knowledge will be used to qualify the interviewguide.
Read more
8 semi-structured group interviews and 3 individual interviews will be conducted and tape recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as a co-moderator. The groups will contain 4 - 12 participants.
The interview guide will be developed with a Scottish behavioural marker system as a framework, drawing upon the literature as well as the observations. It will contain questions regarding leadership, communication, teamwork, situation awareness and decision making to facilitate a discussion about surgeons' good and poor behaviours.
Material: Data will be collected in two hospitals in the capital Region of Denmark, Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups is included to get the perspectives of the surgeons' team members since international studies have demonstrated differences of opinion regarding the perceived quality of teamwork amongst operating theatre staff. This study will be the first to build in the opinions of the team members into a behavioural marker system. 3 individual interviews with surgeons will afterwards conducted in one of the hospitals to get a more in-depth discussion.
Data analysis and statistics: The interviews will be fully transcribed and analysed using qualitative method of systematic text condensation. Power calculations are not relevant in this qualitative study. Accepted guidelines state that the number of participants in each group should range between 5 and 15 and the data are from two large university hospitals receiving different patient categories to ensure a certain representative sample of informants.
- Conditions
- Surgical Behaviour in the Operating Room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Behaviour in the Operating RoomStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Doris Ostergaard, M.D, Study chair, Danish Institute for Medical Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334411
- Sponsor's protocol ID
- NTS-1-LS
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Spanager L, Lyk-Jensen HT, Dieckmann P, Wettergren A, Rosenberg J, Ostergaard D. Customization of a tool to assess Danish surgeons non-technical skills in the operating room. Dan Med J. 2012 Nov;59(11):A4526.
PubMed 23171747
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Good and Poor Surgical Behaviour in the Danish Operating Room
- ClinicalTrials.gov ID
- NCT01334411
- Acronym / sponsor ID
- NTS-1-LS
- Conditions
- Surgical Behaviour in the Operating Room
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Apr 2011 (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.
Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery.
Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with empirical background knowledge of observed surgical behaviour as well as an understanding of surgical culture. The knowledge will be used to qualify the interviewguide.
8 semi-structured group interviews and 3 individual interviews will be conducted and tape recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as a co-moderator. The groups will contain 4 - 12 participants.
The interview guide will be developed with a Scottish behavioural marker system as a framework, drawing upon the literature as well as the observations. It will contain questions regarding leadership, communication, teamwork, situation awareness and decision making to facilitate a discussion about surgeons' good and poor behaviours.
Material: Data will be collected in two hospitals in the capital Region of Denmark, Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups is included to get the perspectives of the surgeons' team members since international studies have demonstrated differences of opinion regarding the perceived quality of teamwork amongst operating theatre staff. This study will be the first to build in the opinions of the team members into a behavioural marker system. 3 individual interviews with surgeons will afterwards conducted in one of the hospitals to get a more in-depth discussion.
Data analysis and statistics: The interviews will be fully transcribed and analysed using qualitative method of systematic text condensation. Power calculations are not relevant in this qualitative study. Accepted guidelines state that the number of participants in each group should range between 5 and 15 and the data are from two large university hospitals receiving different patient categories to ensure a certain representative sample of informants.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The interview informants are health care personell in two Danish Hospitals as described in the project description
Key inclusion criteria (1 listed)
- medical professionals at Rigshospitalet and Herlev Hospital
Key exclusion criteria (0 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
Not reported in the source record.
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 13 Apr 2011.
- Derived from this study: PubMed 23171747Spanager L, Lyk-Jensen HT, Dieckmann P, Wettergren A, Rosenberg J, Ostergaard D. Customization of a tool to assess Danish surgeons non-technical skills in the operating room. Dan Med J. 2012 Nov;59(11):A4526.
Related trials for Surgical Behaviour in the Operating Room
Not yet recruiting
Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating Room
Stress, Stress and Burnout
Enrolling by invitation
The Impact of Classical Music on Performance in Robotic Surgery Simulation
Surgical, Surgical Behaviour in the Operating Room
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.
Doris Ostergaard, M.D study chair
Danish Institute for Medical Simulation
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 Surgical Behaviour in the Operating Room, run by Herlev Hospital 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 0 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 13 Apr 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334411, which also lists 1 linked publication.
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 13 Apr 2011.