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Staff Experiences in Robotic Theatres

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ClinicalTrials.gov Identifier: NCT03453736
Recruitment Status : Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Brief 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.


Condition or disease Intervention/treatment
Robotic Staff Experiences Other: No intervention

Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Qualitative Study of Staff Experiences and Practices Within the Robotic Theatre Setup
Estimated Study Start Date : June 6, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Robotic procedures
Experiences and practices in Robotic theatres will be studied via semi-structured interviews with staff as well as team observations during real time robotic surgery. As the study is a qualitative one, data collection will continue till we reach saturation of theoretical categories. We expect 20 interviews and 10 observations to suffice.
Other: No intervention
This is a qualitative study involving staff interviews and observations. No intervention is being applied.

Non-Robotic procedures

Staff involved in robotic surgery will have almost definitely worked in non-robotic theatres ie major abdominal and laparoscopic. Staff interviews will explore differences in experiences and practices between these different theatre setups.

In addition, we aim to observe further 5 non-robotic procedures to evaluate staff teamwork and communication within the more regular theatre setup.

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




Primary Outcome Measures :
  1. Robotic staff experiences. [ Time Frame: 1 year ]
    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.

  2. Robotic staff practices [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Staff communication in robotic theatres. [ Time Frame: 1 year ]
    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.

  2. Staff teamwork [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be theatre staff, from any surgical discipline, who are involved in robotic surgery practice at University Hospitals of Leicester and Cambridge University Hospital. This includes, but not limited to surgeons (primary and assistants), nurses (scrub, circulating, or student), anaesthetists (including trainees) and operating department practitioners (ODP).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453736


Contacts
Contact: Dina El-Hamamsy, MBBCh, MSc, MRCOG +44(0)1162297257 deh15@le.ac.uk
Contact: Douglas Tincello, BSc MBChB MD FRCOG FHEA +44 (0)116 252 5451 dgt4@le.ac.uk

Sponsors and Collaborators
University of Leicester

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03453736     History of Changes
Other Study ID Numbers: 0647
237227 ( Other Identifier: Integrated Research Application System (IRAS) )
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Leicester:
Robotic surgery
theatre staff
teamwork
patient safety