Intelligent Operating Room

NCT03955614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-04-11

No results posted yet for this study

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

Interventions

OTHER

pedal-controlled GoSurgeryTM

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.

OTHER

ML-controlled GoSurgeryTM

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.

OTHER

NoGo

The operating theatre environment is recorded to observe baseline teamwork.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Sanjay Purkayastha, MBBS MD FRCS · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955614 on ClinicalTrials.gov