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 Snapshot
- Phase
- Not Applicable
- Sponsor
- Imperial College London
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Does GoSurgeryTM affect surgical training overtime?
Study Overview
Brief 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.
Detailed Description
Primary emergency and elective general surgery procedures at St Mary's Hospital, Imperial College Healthcare Trust, Chelsea and Westminster University Hospital Trusts and University College London University Hospital, under the care of participating surgical teams shall be considered.
The study will be set up as a sequential cohort study, comparing the performance of surgical teams, before and after the introduction of GoSurgeryTM software.
We will include three Bariatric teams from St Mary's, University Hospital and Chelsea and Westminster Hospitals.
In the three cohorts, videocameras and microphones will be positioned in the operating theatre in order to capture all events and conversations taking place from the beginning to the end of each case.
As is routine surgical practice, once the patient has been prepared for surgery, the keyhole (laparoscopic) camera will be connected to the laparoscopic stack to be projected onto the operating room screens. Recording will be started at the time of inserting the camera into the patient's abdomen, as is protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Does GoSurgeryTM affect surgical training overtime?
Time Frame: After operative cases as detailed above throughout 2 phases, approximately 4-5 months.
Members of the surgical team will be asked to fill out study-specific questionnaires including open questions and Likert-Style questionnaires relating to their perceived learning experience (Strongly Disagree, Tend to Disagree, Neither Agree nor Disagree, Tend to Agree, Strongly Agree). The questionnaire will take approximately 5 minutes to complete. Operating theatre staff questionnaires will be handed out in the interventional phases after the first 3 lists and then after the 5th list and the last list.
Does GoSurgeryTM affect delays in the operating theatre?
Time Frame: After the surgery, within 1-24 months.
Audio-video recordings of the surgery will be examined to measure timing of each operative step and to identify if any delays were incurred. These delays will be labelled according to causation eg equipment retrieval, equipment failure, lack of staff, lack of bed etc.
Does GoSUrgeryTM affect mental demand overtime when operating?
Time Frame: After operative cases as detailed above throughout 3 phases, approximately 4-6 months.
Members of the surgical team will be asked to fill out a validated SURG-TLX questionnaire assessing mental demands. The Surgery Task Load Index (SURG-TLX) is a multidimensional rating scale that has six bipolar dimensions: Mental demands, Physical demands, Temporal demands, Task complexity, Situational stress, Distractions. These are weighted from low to high on a numerical scale, with high signifying higher perception and low lower perception, as well as in a pairwise comparisons of applicability. The weighted scales are utilised to calculate a total workload score as well as being used individually to score each domain. During all 3 phases, we will ask SURG-TLX questionnaire to be completed after first 3 cases of each type of surgery (eg first three sleeve gastrectomies).
Does GosurgeryTM affect teamwork?
Time Frame: audio-video recordings of the operation shall be taken lasting the entire duration of the case from when patient enters anaesthetic room to when they exit they operating theatre. they will be scored within 1-3 months.
The Observational Teamwork Assessment for Surgery (OTAS) will be measured for each case, this is an assessment instrument which is used to evaluate quality of teamwork in clinical settings.OTAS distinguishes between three phases of surgery: Pre-operative, intra-operative and post-operative; and the three core operating theatre sub-teams: surgical, nursing and anaesthetic. OTAS evaluates 5 teamwork behaviours: Communication, Coordination, Cooperation /Back up behaviour, Leadership, Team Monitoring/ Situational Awareness. In total OTAS generates 45 behavioural evaluations per observed surgical procedure: 5 behaviours x 3 sub-teams x 3 operative phases. These evaluations are expressed on a 0 to 6 anchored scale, with higher scores indicating higher quality teamwork.
Does GoSurgeryTM affect operative timings?
Time Frame: After the surgery, within 1-24 months.
Surgical performance will be assessed by measuring operative timings as per the video recordings of the operation.
Secondary Outcomes
- Does GoSurgeryTM affect patient outcomes (the presence of complications )?(from Day of Surgery to 7 months after surgery.)
- Does GoSurgeryTM influence cost of wasted equipment?(After the surgery, within 1-24 months.)
- Does GoSurgeryTM affect patient outcomes (duration of hospital stay)?(from Day of Surgery to 7 months after surgery.)
- How does GosurgeryTM affect team performance?(After the surgery, within 1-24 months.)
- Evaluation of the Machine Learning algorithm to correctly detect operative steps of the procedures.(After the surgery, within 1-24 months.)