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clinical trial
if you have
Surgical Behaviour in the Operating Room
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This is an observational trial.
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The purpose

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.

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Tris trial is registered with FDA with number: NCT01334411. The sponsor of the trial is Herlev Hospital and it is looking for 0 volunteers for the current phase.
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