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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03453736
Other study ID # 0647
Secondary ID 237227
Status Completed
Phase
First received
Last updated
Start date July 8, 2018
Est. completion date March 21, 2019

Study information

Verified date April 2021
Source University of Leicester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety. The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 21, 2019
Est. primary completion date March 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Robotic theatre staff as above. 2. Willing and able to participate. 3. Good command of the English language. Exclusion Criteria: 1. Theatre staff not involved in robotic surgery. 2. Participants not willing / unable to participate. 3. Staff that have not worked in a conventional theatre setup before. 4. Inability to read/speak/understand English. 5. Lack of capacity for consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This is a qualitative study involving staff interviews and observations. No intervention is being applied.

Locations

Country Name City State
United Kingdom University Hospitals of Leicester NHS Trust Leicester

Sponsors (1)

Lead Sponsor Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Robotic staff experiences. This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method. 1 year
Primary Robotic staff practices This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method. 1 year
Secondary Staff communication in robotic theatres. This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method. 1 year
Secondary Staff teamwork This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method. 1 year