A Feasibility Study to Evaluate the Use of Digital Technologies and Artificial Intelligence (AI) to Enhance Surgical Team Training and Performance in the Operating Theatre and to Improve Efficiency and Patient Outcomes
Trial ID: NCT03955614
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2019-10-04
Completion date: 2022-10-01
Sponsor: Imperial College London
Conditions: Surgery
Interventions: pedal-controlled GoSurgeryTM; ML-controlled GoSurgeryTM; NoGo
Locations: Imperial College Hospitals NHS Trust
Countries: United Kingdom
Enrollment: 150
Age range: 18 Years - None
Sex: ALL

Summary:
The widely varied practice of surgery, alongside rapidly expanding specialised knowledge and evolving technology as well as the fast turnover of operating theatre staff means they often face unfamiliar operations, techniques and equipment. To the investigator's knowledge, there is no formal induction for the work undertaken specifically within the operating theatre.

Many studies have shown that standardised practices, formal training and mental rehearsal improve surgical performance.

In this context, Artificial Intelligence (AI) is expected to have vast applications in surgery, particularly through standardisation, clinical decision and training support as well as patient-centred care optimisation.

Digital SurgeryTM developed GoSurgeryTM software to consolidate induction processes, support training and achieve standardised surgical practices, ultimately improving surgical performances and patient outcomes.

GoSurgeryTM allows surgeons to prepare step-by-step standardised workflows of procedures, including equipment, tips and warnings.

In preparation for surgery, workflows can used by operating team staff as a form of induction and mental rehearsal. During the surgery, using pedal-controlled tablets, relevant information for each step of the procedure is presented. GoSurgeryTM has developed AI computer vision to recognise the steps and automatically present the workflows without user-intervention.

After the surgery, the AI will allow surgeons to review their performances uploaded onto a personal virtual Hub and compare timing of steps to their previous repository of cases, as well as giving them the ability to share any interesting or difficult cases, supporting learning opportunities and monitoring of progression.

This feasibility study sets the bases to test the ability of GoSurgeryTM to improve induction processes, team performance, surgical training and patient outcomes.

The research will compare preparedness and performance of operating staff with/without the use of GoSurgeryTM, through questionnaires, observational team assessments, technical measures and patient outcomes.

Data will be collected at Imperial College Trust, Chelsea and Westminster Hospital and University College Hospital on patients undergoing general surgery. Anonymised images of keyhole surgery shall be analysed in collaboration with Digital SurgeryTM to develop the AI computer vision software.

Eligibility criteria:
Patient Inclusion Criteria:

* patients undergoing any elective general surgery procedures;
* patients undergoing emergency general surgery procedures where the urgency of the procedure does not preclude gaining informed consent and setting up the necessary equipment;
* all patients must have capacity and be able to give consent either in English or through the use of an interpreter.

Operating theatre staff inclusion criteria:

\- any staff whom have been allocated to the case

Patient Exclusion criteria shall include:

* patients undergoing immediate or urgent interventions whereby clinical urgency impedes the appropriate consent process to take place or the equipment to be set up;
* patients whom do not have capacity;
* patients whose level of English is not sufficient to give consent and an interpreter is not available.

Operating theatre staff exclusion criteria:

\- there are no exclusion criteria for the operating theatre staff.

Outcomes:
Does GosurgeryTM affect teamwork?; Does GoSurgeryTM affect surgical training overtime?; Does GoSurgeryTM affect delays in the operating theatre?; Does GoSUrgeryTM affect mental demand overtime when operating?; Does GoSurgeryTM affect operative timings?