Intelligent Operating Room

NCT03955614 | Unknown DMC

• 1 other identifier: 19SM4984
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Surgery

Outcome Measures

Primary Outcomes (5)

• Does GosurgeryTM affect teamwork?

  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.

  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.

• Does GoSurgeryTM affect surgical training overtime?

  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.

  After operative cases as detailed above throughout 2 phases, approximately 4-5 months.

• Does GoSurgeryTM affect delays in the operating theatre?

  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.

  After the surgery, within 1-24 months.

• Does GoSUrgeryTM affect mental demand overtime when operating?

  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).

  After operative cases as detailed above throughout 3 phases, approximately 4-6 months.

• Does GoSurgeryTM affect operative timings?

  Surgical performance will be assessed by measuring operative timings as per the video recordings of the operation.

  After the surgery, within 1-24 months.

Secondary Outcomes (5)

• Does GoSurgeryTM affect patient outcomes (the presence of complications )?

  from Day of Surgery to 7 months after surgery.

• 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.

• Does GoSurgeryTM influence cost of wasted equipment?

  After the surgery, within 1-24 months.

Study Arms (3)

St Marys Hospital

EXPERIMENTAL

25 cases will be observed before the intervention and then 25 cases will be observed with the intervention

Other: pedal-controlled GoSurgeryTM; Other: ML-controlled GoSurgeryTM; Other: NoGo

University College Hospital

EXPERIMENTAL

25 cases will be observed before the intervention and then 25 cases will be observed with the intervention

Other: pedal-controlled GoSurgeryTM; Other: ML-controlled GoSurgeryTM; Other: NoGo

Chelsea and Westminster Hospital

EXPERIMENTAL

25 cases will be observed before the intervention and then 25 cases will be observed with the intervention

Other: pedal-controlled GoSurgeryTM; Other: ML-controlled GoSurgeryTM; Other: NoGo

Interventions

pedal-controlled GoSurgeryTM OTHER

Members of the surgical team are given operative instruction workflows to use in preparation of a specific operation and to consult during the operation if needed. The workflows are controlled by the surgical staff using pedals. The operating theatre environment is recorded to observe how teamwork may be affected by the intervention.

Chelsea and Westminster Hospital; St Marys Hospital; University College Hospital

ML-controlled GoSurgeryTM OTHER

Members of the surgical team are given operative instruction workflows to use in preparation of a specific operation and to consult during the operation if needed. The workflows are projected onto screen based on the machine learning algorithm's determination of current operative step. The operating theatre environment is recorded to observe how teamwork may be affected by the intervention.

Chelsea and Westminster Hospital; St Marys Hospital; University College Hospital

NoGo OTHER

The operating theatre environment is recorded to observe baseline teamwork.

Also known as: baseline observation

Chelsea and Westminster Hospital; St Marys Hospital; University College Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- any staff whom have been allocated to the case

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Hospitals NHS Trust

London, W21NY, United Kingdom

RECRUITING

Study Officials

• Sanjay Purkayastha, MBBS MD FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Winter Beatty, MBBS MSc

CONTACT

020331226666; jasmine.winterbeatty@nhs.net

Ruth Nicholson

CONTACT

020759 41862; r.nicholson@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Surgical teams in participating departments will be observed whilst performing 25 cases as per their standard, in order to establish baseline measurements. Subsequently, the Gosurgery software will be introduced and 25 cases utilising the new technology will be assessed.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: May 20, 2019
• Study Start: October 4, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)