NCT03453736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

February 19, 2018

Last Update Submit

April 29, 2021

Conditions

Keywords

Robotic surgerytheatre staffteamworkpatient safety

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Staff communication in robotic theatres.

    1 year

  • Staff teamwork

    1 year

Study Arms (2)

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

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

Interventions

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

Non-Robotic proceduresRobotic procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Robotic theatre staff as above.
  • Willing and able to participate.
  • Good command of the English language.

You may not qualify if:

  • Theatre staff not involved in robotic surgery.
  • Participants not willing / unable to participate.
  • Staff that have not worked in a conventional theatre setup before.
  • Inability to read/speak/understand English.
  • Lack of capacity for consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 5, 2018

Study Start

July 8, 2018

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations