SurgeryinOrNCT03955614
Intelligent Operating Room
A study testing NoGo in people with Surgery, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- NoGo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Hospitals NHS Trust
London, W21NY
Jasmine Winter Beatty, MBBS BSc, 02033126666, jasmine.winterbeatty@nhs.net
About this study
Official title: 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
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.
Read more
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.
Read the 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.
in the intervention phase, GoSurgeryTM workflows will be made available to the intervention group for preparation before the cases and will be displayed within the operating theatre during the operation.
They will be controlled though pedals that allow to move backwards and forwards through the workflow.
When using GoSurgeryTM with visual recognition software, the keyhole video footage shall be directly extracted using local transfer over a closed wired network.
This video shall be fed into the visual recognition software algorithm. The software shall then recognise the specific part of the procedure being performed and display the relevant information on dedicated screens showing different views for different members of the team, eg surgeon view or scrub nurse view. Videos will be used to train the machine learning software to recognise the different steps of different operations so that it may then replace the pedal controls.
Members of the surgical team shall be asked to complete questionnaires before and/or after the cases.
- Conditions
- Surgery
- Being tested
- pedal-controlled GoSurgeryTM, ML-controlled GoSurgeryTM, NoGo
- Keywords
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedal-controlled GoSurgeryTMOther
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.
ML-controlled GoSurgeryTMOther
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.
NoGoOther
Also called baseline observation
The operating theatre environment is recorded to observe baseline teamwork.
| Study group | Role | What they receive |
|---|---|---|
| St Marys Hospital | Experimental | 25 cases will be observed before the intervention and then 25 cases will be observed with the intervention Receives: 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 Receives: 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 Receives: Other: pedal-controlled GoSurgeryTM; Other: ML-controlled GoSurgeryTM; Other: NoGo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: After the surgery, within 1-24 months.
Secondary outcomes (5)
Does GoSurgeryTM affect patient outcomes (the presence of complications )?
Patient medical records will be reviewed for up to 7 months after the surgery and examined for the presence of any complications as defined by the Clavien-Dindo classification.
ClavienDindo:
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included.
Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management Grade V Death of a patient
Measured: from Day of Surgery to 7 months after surgery.
Does GoSurgeryTM affect patient outcomes (duration of hospital stay)?
Patient medical records will be reviewed for up to 7 months after the surgery to determine time spent in hospital as a result of the procedure, including Length of stay (days) postoperatively, re-admissions or re-presentations to A\&E .
Measured: from Day of Surgery to 7 months after surgery.
How does GosurgeryTM affect team performance?
Identification of other factors associated with the use of the GosurgeryTM but not directly caused or intended, that may contribute to better team work. This will be completed through the assessment of open feedback questions on questionnaires completed by team members after operative cases and review of audio-video recordings.
Measured: After the surgery, within 1-24 months.
Evaluation of the Machine Learning algorithm to correctly detect operative steps of the procedures.
Manual and Machine learning Time stamps for different steps of different procedures will be compared to determine accuracy. This will be performed on approximately 20-30 videos of the keyhole surgery.
Measured: After the surgery, within 1-24 months.
Does GoSurgeryTM influence cost of wasted equipment?
Audio-video recordings of the surgery will be examined to identify any financial cost incurred as a result of incorrect equipment being opened due to lack of familiarity with the procedure or the surgeons' preferences.
Measured: After the surgery, within 1-24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start4 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Purkayastha, MBBS MD FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955614
- Sponsor's protocol ID
- 19SM4984
- Acronym
- inOr
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03955614
- Acronym / sponsor ID
- inOr / 19SM4984
- Conditions
- Surgery
- Keywords
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
in the intervention phase, GoSurgeryTM workflows will be made available to the intervention group for preparation before the cases and will be displayed within the operating theatre during the operation.
They will be controlled though pedals that allow to move backwards and forwards through the workflow.
When using GoSurgeryTM with visual recognition software, the keyhole video footage shall be directly extracted using local transfer over a closed wired network.
This video shall be fed into the visual recognition software algorithm. The software shall then recognise the specific part of the procedure being performed and display the relevant information on dedicated screens showing different views for different members of the team, eg surgeon view or scrub nurse view. Videos will be used to train the machine learning software to recognise the different steps of different operations so that it may then replace the pedal controls.
Members of the surgical team shall be asked to complete questionnaires before and/or after the cases.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| St Marys Hospital | Experimental | Other: pedal-controlled GoSurgeryTM, Other: ML-controlled GoSurgeryTM, Other: NoGo25 cases will be observed before the intervention and then 25 cases will be observed with the intervention |
| University College Hospital | Experimental | Other: pedal-controlled GoSurgeryTM, Other: ML-controlled GoSurgeryTM, Other: NoGo25 cases will be observed before the intervention and then 25 cases will be observed with the intervention |
| Chelsea and Westminster Hospital | Experimental | Other: pedal-controlled GoSurgeryTM, Other: ML-controlled GoSurgeryTM, Other: NoGo25 cases will be observed before the intervention and then 25 cases will be observed with the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedal-controlled GoSurgeryTMMembers 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 | Chelsea and Westminster Hospital, St Marys Hospital, University College Hospital |
| ML-controlled GoSurgeryTMMembers 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 | Chelsea and Westminster Hospital, St Marys Hospital, University College Hospital |
| NoGoAlso: baseline observationThe operating theatre environment is recorded to observe baseline teamwork. | Other | Chelsea and Westminster Hospital, St Marys Hospital, University College Hospital |
Primary outcome
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 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 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.
5 secondary outcomes
Does GoSurgeryTM affect patient outcomes (the presence of complications )?
Time frame: from Day of Surgery to 7 months after surgery.
Does GoSurgeryTM affect patient outcomes (duration of hospital stay)?
Time frame: from Day of Surgery to 7 months after surgery.
How does GosurgeryTM affect team performance?
Time frame: After the surgery, within 1-24 months.
Evaluation of the Machine Learning algorithm to correctly detect operative steps of the procedures.
Time frame: After the surgery, within 1-24 months.
Does GoSurgeryTM influence cost of wasted equipment?
Time frame: After the surgery, within 1-24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Purkayastha, MBBS MD FRCS principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NoGo in people with Surgery, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Winter Beatty, MBBS MSc (020331226666 ext. 21955, jasmine.winterbeatty@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.