Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05884385 |
| Other study ID # |
DEV046 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2023 |
| Est. completion date |
October 25, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Lancaster University |
| Contact |
Abdul Shugaba |
| Phone |
+44 (0) 1524 593602 |
| Email |
a.shugaba[@]lancaster.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study Design - A Counterbalanced Study
Aims - To determine the effect of a) warm-up exercises and b) mental visualisation on the
musculoskeletal demands and cognitive demands respectively during robot-assisted laparoscopic
surgery.
Outcome Measures -
1. EMG measurements of frequency and amplitude across muscle fibres.
2. EEG measurements of peak alpha power, and alpha spindle duration and amplitude.
Study Participants and Eligibility - Surgeons who have certificates of completion of training
(CCT) and performing surgical procedures using the minimally invasive techniques of RALS.
Planned Size of Sample - The investigators have chosen the higher value for our power
calculation (an effect size of 0.24) which requires 10 surgeons per condition performing 1 -2
operations for 80% power to detect a difference between conditions, at an alpha of 0.05.
Planned Study Period-Duration - Each surgeon will be required to participate in the study for
approximately 3 - 4 weeks performing 3 surgical procedures and based on estimates that
surgeons routinely perform an average of 1 robotic procedure per week we anticipate the study
will run for 6 months.
Research Question - Does structured simulated warm-up exercises prior to performing surgery
improve surgeons' ergonomic awareness and maintain the low muscle fatigue impact associated
with RALS? The investigators also hypothesize that mental imagery, inducing a flow state
associated with overall cortical synchronisation could decrease cognitive demands experienced
by surgeons and potentially mitigate against the cognitive fatigue surgeons experience whilst
performing procedures.
Description:
BACKGROUND There is an increased utilisation of minimally invasive surgery (MIS) by virtue of
it being more beneficial to patients(1, 2), however, an increase in musculoskeletal (MSK)
demands is observed when the modality of standard laparoscopic (LS) techniques are used
compared with robot-assisted laparoscopic techniques (RALS)(3, 4). Studies have further
highlighted that RALS is significantly associated with decreased musculoskeletal demands for
surgeons(5-7), including findings from our recent study exploring the demands of RALS and LS
surgery (MURALS study - NCT04477746).
Although most studies additionally observe that surgeons experienced less cognitive demands
with RALS(4, 8, 9), the MURALS study on the other hand found that the favourable MSK effects
associated with RALS come with a "cost" of concomitantly increasing surgeons' attentional
demands. This finding is associated with the design of the robotic console's viewing cart
which has a binocular design displaying high-definition 3-dimensional images similar to
virtual reality headsets, thereby requiring fusion of images from both eyes(10) to produce
clear images of the operating field through the process of stereopsis. Also, this design of
the viewing cart additionally acts to isolate the visual senses and block out other
distractions within the surgeon's visual field.
The modern technology of RALS, therefore, offers better ergonomic advantages which could
protect surgeons from adverse MSK effects and potentially prolong their surgical careers. The
consequent effect of this would be an increase in the years' surgeons remain in active duty
thereby being able to operate and provide life-changing treatments to an additional number of
patients over the span of their careers.
Warm-up exercises, such as aerobic or stretching exercises and performing simulated tasks,
all represent types of interventions associated with improved task performance, decreased
completion times, and reduced errors(11). Warm-up exercises are routinely practiced by
athletes before competing and amongst musicians and dancers prior to performances(12, 13)
which are complex psychomotor tasks requiring high cognitive function and coordinated motor
skill. Similarly, surgeons performing fundamental surgical skills like suturing performed
simulations on mobile devices(14) or on surgical simulators(15) prior to being assessed using
validated global rating scales like the Kundhal or Reznick scale demonstrated improved task
performance, also consistent with the findings in a systematic review on the effect of
warm-up exercises on surgical performance(16).
Another simple and inexpensive tool utilised by athletes to enhance performance is mental
visualisation or mental imagery(17) which is the cognitive rehearsal of tasks in the absence
of physical movements for the purpose of mental rehearsal, relaxation or goal-setting
purposes(18). Whilst athletes experience a myriad of different mental states during task
performance, this technique of mental imagery has been shown to improve optimal performance
in athletes(19) by inducing, a flow state - which is characterized by automatic information
processing without conscious thinking by suppressing prefrontal cortex activity
temporarily(20). There is also an association between mental imagery and an observed greater
power of alpha waves(21, 22) especially associated with the parietal (somatosensory
processes) and occipital (visual processes) cortex(23, 24). Studies in neurophysiology have
clearly established that the neuroplastic changes observed during mental visualisation are
similar to those which occur when physically performing tasks(25, 26) due to the fact that
performed or imagined movements stimulate the same neurons, engaging comparable patterns of
connectivity between cortical motor regions(27).
Mental imagery has also been studied amongst surgeons, using the mind as a simulator for
prior rehearsal of steps involved in a procedure with consequent improved overall performance
and enhanced motor skills observed when surgeons performed both simple(28) or complex(29)
procedures. Mental visualisation could therefore potentially serve as a tool for offsetting
the cognitive demands associated with RALS.
The time-pressured, demanding nature of surgeons' jobs together with the working time
directive leaves a little amount of time for training in methods to alleviate the demands
associated with performing surgery. Therefore, warm-up exercises and mental visualisation can
serve as simple, readily available, and cost-effective ways through which surgeons can
maintain lower MSK demands and lessen the cognitive demands associated with RALS surgeons.
The Rationale for Current Study The investigators hypothesise that structured simulated
warm-up exercises prior to performing surgery aimed at improving surgeons' ergonomic
awareness will maintain the low muscle impact of RALS.
The investigators also hypothesize that mental imagery, inducing a flow state associated with
overall cortical synchronisation(30) could decrease cognitive demands experienced by surgeons
and potentially mitigate against the cognitive fatigue surgeons experience whilst performing
procedures, as observed in athletes demonstrating high alpha event-related synchronization
when performing tasks(31).
The aim of this proposed study is to investigate the effect of warm-up exercises and mental
visualisation in mitigating against the cognitive demands associated with RALS whilst
retaining the advantage of decreased muscle demands.
Study Objectives To determine the effect of a) warm-up exercises and b) mental visualisation
on the musculoskeletal demands and cognitive demands respectively during robot-assisted
laparoscopic surgery.
To address these aims, the investigators will subject surgeons to three types of conditions:
no intervention, simulated exercises pre-surgery as a form of warm-up exercise, and mental
visualisation. These will be administered to surgeons whilst using cutting-edge physiological
and neuroscientific methods to establish the mechanisms and patterns of fatigue associated
with robot-assisted laparoscopic surgery.
Study Design and Data Collection Methods Study Setting Surgeons will be invited to take part
in the study from East Lancashire Hospitals NHS Trust through their trust email addresses.
Interested surgeons will then provide written informed consent before participating in the
study, then they will be provided with study identification numbers in a sequential manner. A
randomisation process maintaining the basic principles of sequence generation, allocation
concealment, and implementation will be carried out using GraphPad software. This will
provide the sequence of how each surgeon will be subjected to the different study conditions.
To avoid any unnecessary burdens, prior to the day of the first surgery, surgeons will
complete validated questionnaires. These will include one regarding general health conditions
using SF36 Health questionnaire and one regarding physical activity level using the
International Physical Activity Questionnaire (IPAQ). Surgeons' basic demographic
characteristics will be recorded on the first day of surgery including; age, BMI, handedness,
glove size, and years of experience.
As part of the standard process of consenting patients for surgery, the surgeons or a member
of the research team will inform the patients about the decision and consent provided by
their surgeon to participate in the research study i.e. to allow data collection on their
surgeon. This is detailed in section 4.7.
Robotic surgical procedures based on the specialty (e.g., nephrectomies, bowel resections,
hysterectomies, hepatectomies) will be used for data collection by fitting Surgeons with both
EMG and EEG wireless devices. This study is being conducted in real-life surgeries and
controlling for conditions between operations will be uniquely challenging, therefore any
operations where complications result in the surgery taking beyond 50% of the mean average
surgery time, to prevent this skewing the data toward an effect increased musculoskeletal and
cognitive demands. Data already collected will be stored and if applicable, analysis to the
point of exclusion will be carried out, Because the surgical procedures are different between
specialties, predefined points of interest (POI) which are similar between the various
surgical procedures will be used as points of interest for data recording. These points of
recording provide discrete areas of comparison because, the skills and techniques used at
these points are similar and are expected to provide similar challenges to the surgeons and
they will include the dissection of vessels, mobilisation of organs, dissection of target
tissues, and suturing.
Study Outcome Measures Measurement of musculoskeletal demands (EMG) Electromyography (EMG)
will be used to determine the varying degrees of musculoskeletal demands experienced by
surgeons in the different experimental conditions whilst performing surgery using RALS. This
will be achieved using Surface EMG which is a non-invasive procedure that measures muscle
activity by recording the electrical signals generated within muscle fibres during
contractions. EMG has been used to assess MSK demands in different settings, in athletes(35),
dentists(36), and in surgeons(37), more recently in our MURALS study.
EMG data will be collected for 180 seconds at the predefined POIs throughout the surgery. The
changes in muscle electrical activity noted on EMG will be used as a marker of MSK demands.
For example, a reduction in amplitude with a corresponding increase in frequency indicates
fatigue being induced, as the muscle's recruitment has changed to deal with the demand.
Monitoring with be performed using the Four muscle groups (Biceps, Deltoid, Trapezius, and
latissimus dorsi muscles) frequently associated with increased MSK demands when surgery is
performed using MIS techniques(5). ). Because RALS is performed by surgeons sitting at the
console, with a brow- and arm-rest, this considerably lowers the workload on the lower
limbs(5), therefore these will not be included to avoid any confounding factors.
EMG protocol. Surgeons will scrub up and place the robotic ports required to insert
instruments into the body cavity where the surgery will be performed. They then dock the
robot's instrument cart before un-scrubbing. Before they proceed to the robotic control
console, surgeons will be fitted with wireless EMG sensors. This will be done following
standard and established procedures, over the skin which overlies the bellies of the four
muscles and parallel to the muscle's fibres having an inter-electrode distance of 20mm(38).
The EMG data collection procedures will follow established protocols regarding site
preparation and electrode placement, as well as data collection, processing, and
normalisation(38). A wireless EMG system has been selected so that it is minimally invasive
and does not impede a surgeon's movement with wires.
Measurement of cognitive demands (EEG) Electroencephalography (EEG) will be used to determine
the varying degrees of cognitive demands surgeons in the different experimental conditions
experience whilst performing surgery using RALS. EEG measures the ongoing electrical activity
of the brain across the scalp (standard EEG) or within the brain matter (intracranial EEG)
during a given task. The investigators will utilise a wireless standard EEG device, which is
a non-invasive technique and provides physiological quantification of an individual's
neurophysiological state in real-time, which can be linked to cognitive function. This
approach removes reliance on subjective measures such as self-report or questionnaires.
Different brain waves are captured by EEG which reflect neural oscillations occurring at
different frequencies.
The alpha-band frequency (8- 13 Hz) which is associated with a relaxed wakefulness state, and
decreases with concentration (40) has predominantly been used in studies as a proxy to index
cognitive fatigue(41), however, beta wave activity (frequency of 13 - 20 Hz) has also been
noted to increase with alertness level and decrease during drowsiness(42-44).
Alpha waves have been used in studies to measure cognitive fatigue both in drivers(45), train
operators(46), and for the first time in surgeons in our MURALS study. The alpha-wave
activity is considered to reflect individual fatigue states and can be quantified in terms of
their peak frequency, duration, and amplitude, giving rise to an individual's alpha signature
(47)(48). There is also a large precedent in the literature relating observed changes in
alpha power to be specifically associated with visual attentional demands(49). High alpha
power has been associated with 'idling' of the cortex, when the brain is not actively
processing information, and a decrease in alpha power from baseline indicates a change from a
resting to an activated brain state because the cortical modules in visual areas display a
smaller degree of cooperation and are less synchronized as they maintain visual encoding and
processing, relative to baseline(49).
Further analysis of EEG data to scrutinize the behaviour and trend of beta wave activity will
serve to strengthen observed findings in the study.
EEG protocol. Whilst surgeons are having EMG electrodes fitted, a similar procedure will be
completed for the wireless Enobio 8 5G wireless EEG device (Neuroelectrics, Cambridge, MA,
USA). Surgeons will be fitted with an appropriate size EEG electrode cap and electrode gel
applied onto the scalp using the wells on the EEG cap. This does not interfere with the
surgeon's comfort and if a surgeon requires the electrode cap to be removed during a
procedure due to any reason, this can be performed seamlessly within a minute and without
breaching sterility. a member of the research team who in addition to being an investigator
on this project, is a medically qualified surgical trainee familiar with the theatre
environment will perform this by asking the surgeon to step aside from the operating table,
the electrode cap removed from any position of their comfort and their surgical cap put back
in place.
Electrodes will be placed over the cortex using the eight channels montage: Cz, Fz, P7, P8,
P3, P4, O1, and O2, in accordance with the international 10-20 Montage system(50, 51).
Similar to the EMG data capture, EEG data will also be collected during data will be
collected for 180 seconds at the predefined POIs throughout the surgery.
Statistics and Data Analysis Plan All collected data will be anonymised and transferred to
Lancaster University for data analysis. Data analysis will be facilitated by a Senior
Lecturer in Research Methods for the undergraduate and postgraduate degrees at the School of
Sport and Exercise Sciences.
EMG data analysis. Using recommended normalisation, sampling, filtering, and smoothing
techniques(39) data will be analysed using EMG Works (Delsys Inc., Boston, MA, USA). Change
in EMG variables, such as frequency and amplitude, across the three experimental conditions,
can provide information on how muscle fibre recruitment has changed and thus, provide an
insight into the effects of the various interventions on MSK demands surgeons' experience.
EEG data analysis. Data will be collected and analysed using ENOBIO NIC1.4 software
(Neuroelectrics, Spain) using standard referencing, sampling, filtering, and smoothing
techniques(52). The different peak alpha powers, and alpha spindle duration and amplitude,
across the three experimental conditions, will be noted. These will provide crucial
information about what the cognitive demands are associated with the different interventions.
Statistical analysis To determine differences in musculoskeletal demands associated with
warm-up exercises and the effect of mental imagery on cognitive demands, a repeated measure
one - way within group ANOVA will be used to analyse the EMG and EEG data respectively to aid
in drawing meaningful conclusions for dissemination using various academic mediums
(publications and conferences).
This study should further highlight the benefits of reduced musculoskeletal demands
associated with RALS and develop a case for incorporating warm-up exercises and mental
visualisation to mitigate against the demands associated with performing minimally invasive
surgery.
Sampling technique Power calculation and Sample Size Determination The investigators have
used an A priori power calculation to compute the required sample size using G*Power 3(32).
Warm-up exercises are estimated to improve surgical performance evidenced by higher Reznick
composite mean scores, with a warm-up score of 22.96 and without warm-up of 19.33, p-value of
≤ 0.001(33). This is similar to the effect in another study showing significant differences
between the warm-up versus the non-warm-up groups noted in median scores, 28.5 and 19.25
respectively, p = 0.042(11). Therefore address the effect of warm-up on surgeons, effect size
is predicted to be (Cohen's d) of 4.62 however pragmatically using a small effect size of
1.5, the investigators will require 4 surgeons in each of warm-up and without warm-up
conditions (total 8) with each surgeon performing 1 - 2 operations during each condition.
Mental imagery improves surgical performance with an effect size of 0.24(25) as reported in a
meta-analysis exploring the role of mental training in the acquisition of surgical skills.
Significant correlation with mental imagery and performance (ranging from 0.47-0.80) were
obtained using Objective Structured Assessment of Technical Skills (OSATS) performance
scores(29), therefore will use data from the 10 surgeons per condition to study this effect.
The investigators have chosen the higher of these three values for our power calculation (an
effect size of 0.24) which requires 10 surgeons per condition performing at least 1 procedure
during each experimental condition, for 80% power to detect a difference between the
conditions, at an alpha of 0.05.
The investigators aim to collect at least 10% additional data per surgeon to mitigate against
factors which can affect data collected as previously noted in the previous similar study the
investigators conducted in surgeons, for example procedures being converted to open surgery
or missing data points due to equipment errors.
4.5 Participant/Sample Recruitment Surgeons: The investigators will screen between 10 - 15
surgeons, aiming to recruit at least 10, who have completed their surgical training and
currently consultant grade surgeons in the National Health Service (NHS) from various
specialties; Urology, Gynaecology, Hepato-pancreatic and Colorectal Surgery, which are
specialties that perform procedures involving abdominal and pelvic organs, where the benefit
of RALS has mainly been demonstrated.
This will be a counterbalanced design where surgeons will be subjected to all 3 conditions;
no interventions performed, simulated exercise - performing pre-surgery warm up tasks, and
mental imagery - performing pre-surgery mental visualisation. All surgeons will undergo the
three conditions which will enable uniformity and facilitate meaningful comparisons between
the study conditions.
Any procedures with complications or significant difficulty will be excluded as this could
serve to confound the findings of the study.
Participant/Sample identification Prior informal information about the study will be
disseminated during surgical departmental meetings and the Blackburn Research Innovation
Development group in general surgery (BRIDGES) meetings. Email addresses of Surgeons will be
identified from the various workforce managers of the surgical departments and Surgeons will
be contacted via their trust emails and will be provided with a brief introduction to the
study and the Participant information Sheet (PIS). Surgeons who meet the inclusion criteria
and perform operations using RALS and have expressed interest in participating in the study
will then be selected and have a meeting arranged for consenting onto the study.
During this meeting a member of the research team will go through the PIS in details and
answer any queries raised and the EMG and EEG processes will be explained and how these fit
into the surgeon's operation. Surgeons who decide to take part will be consented to the most
current and up-to-date PIS and Informed consent form.
Based on the surgeon's diary and theatre lists, a day will be chosen when they have suitable
operations (e.g., Bowel resection) to be performed via RALS and prior email reminder will be
sent to confirm any changes to their general health, or presence of any musculoskeletal
symptoms that may interfere with the study.
Subject coding will be carried out with sequential codes at the point of surgeons being
recruited.
Participant Consent Process All surgeons participating in the study will be provided with
research information packs describing the nature and goals of the research, and study consent
form. This will also contain the contact details of members of the research team who will be
available to clarify and answer any questions. Consent forms must be completed, signed, and
dated after the surgeon has received detailed information about the study and made their
decision. Consenting process will be carried out by any member of the study group.
As part of the consenting process, Surgeons will consent to verbally informing their patients
that, they (the surgeons) are taking part in a research study and assure them the study will
not in way affect their surgery and no data is being collected from them as patients.
Research team members will also inform patients about this, especially when surgeons cannot
facilitate due to clinical commitments or if the initial consent for surgery has already
occurred. For patients being consented on the day of surgery, they will be informed about the
study whilst being provided relevant information on their standard care in the day care unit
by the surgeon or the research team.
No patient data is required hence, a patient consent will not be required for the study.
Consenting surgeons will have dates identified in their diaries when surgical procedures
relevant to the study are selected. Surgeons are free to withdraw from the study without
giving reasons and without prejudice at any time during the study.
Participant Withdrawal Criteria Any study participant may withdraw their participation at any
time by contacting the CI or any members of the research. The surgeons will contact the PI or
any member of the research team, who will note in the participant's record the date of the
request together with the written notification of withdrawal of consent.
Study Interventions
The study involves each surgeon performing three surgical procedures under three different
conditions:
Condition 1 - Surgeons will perform the robotic procedure as they would normally do without
any changes. EMG and EEG monitoring will be conducted by collecting data at predefined POIs.
Condition 2 - Surgeons will perform a preloaded simulated task for 5 minutes on the robotic
console that emulates fundamental skills required to perform robot-assisted laparoscopic
surgery. They will then perform the surgery as they would normally do while undergoing EMG
and EEG monitoring, collecting data at the predefined POIs.
Condition 3 - Mental training scripts based on the different surgical procedures will be
developed using the Mackay nodal model of mental practice. Surgeons will perform 5 minutes of
guided mental visualization using these scripts after performing the initial theatre
briefing. They will then perform surgery as they would normally do while undergoing EMG and
EEG monitoring, collecting data at the predefined POIs.
Overall, the study aims to investigate the impact of these three different conditions on the
surgeons' performance during the surgical procedures, as measured by the EMG and EEG data
collected at predefined POIs.
