Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477746
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2020-07-15
Brief Title:
Surgeon Ergonomics in Robotic-assisted Laparoscopic Vs Standard Laparoscopic Surgery
Sponsor:
Lancaster University
Organization:
Lancaster University
Study Overview
Official Title:
Comparing the Musculoskeletal Demands of Surgeons Performing Robotic-assisted Laparoscopic Surgery and Standard Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MURALS
Brief Summary:
Musculoskeletal injuries amongst surgeons are prevalent This project will determine whether Robotic-assisted Laparoscopic surgery RALS offers superior benefits to surgeons musculoskeletal health than standard laparoscopic surgery LS by identifying the comparative changes in muscle fatigue during RALS Vs LS surgical procedures and additionally identify any cognitive effects of this The Study if successful could help reduce injury rates in surgeons
Detailed Description:
The number of surgical procedures being performed using minimal access techniques is on the rise because of improved recovery times for patients Thus surgeons are performing an increasing number of endoscopiclaparoscopic procedures and are operating for longer periods A recent meta-analysis showed that work-related musculoskeletal injuries amongst surgeons are common 1 and surgeons are amongst those most at risk of work-related musculoskeletal decline 2 Indeed the prevalence of degenerative spinal disease is 17 rotator cuff pathology 18 and degenerative lumbar spine disease is 19 1 Surgeons experience work-related musculoskeletal pain in addition to injury and pain is highly prevalent in the neck 48 shoulder 43 and back 50 13
According to the Office for National Statistics in the UK musculoskeletal problems amongst the workforce are the second most common cause for absence 177 and account for 23 days absenceyear 2 This is not dissimilar in the US where the Bureau of Labour Statistics estimates that 62 of all worker injuries and 32 of missed days from work result from musculoskeletal problems Collectively these data suggest that musculoskeletal problems caused by careers in surgery can reduce physical health which is associated with reduced productivity career longevity and even the quality of patient care
Robotic-assisted laparoscopic surgery RALS is a modern technology that could help mitigate these musculoskeletal problems and thereby improve patient care In comparison to standard laparoscopic surgery LS RALS offers steadier wrist movements with a reduced fulcrum effect thus benefiting the patient 3 There is emerging evidence that RALS is associated with a lower rate of musculoskeletal problems 23-80 than LS 70- 100 1 RALS may therefore be an attractive alternative to LS despite the high cost of equipment and steep learning curve during training
No study has compared the demands of RALS vs LS on musculoskeletal fatigue and subsequent injury risk and whether these changes are underpinned by changes in cognitive fatigue The investigators aim to determine whether a career using RALS is associated with better musculoskeletal health for surgeons than standard LS when performing complex minimally invasive procedures
The hypothesis is that RALS will reduce musculoskeletal fatigue and the prevalence of musculoskeletal injury in surgeons compared to LS If this is true RALS should receive increased support through preserving surgeons health and thereby reducing costs for healthcare providers
Research subjects surgeons and patients Surgeons Investigators will recruit surgeons completing surgical procedures who have similar levels of experience between RALS and LS groups Surgeons will fill a questionnaire regarding working hours and experience physical activity level eg sport bicycling to work or gardening general health conditions and musculoskeletal symptoms within the last 12 months using the Standardized Nordic questionnaires for the analysis of musculoskeletal symptoms 11 The investigators will also quantify body composition height body weight BMI muscle mass fat mass using clinically-validated bioelectrical impedance analysis Surgeons will broadly be matched for age and surgical experience anthropometry and sex Patients To complete the work the investigators will use data from n 40 patients being operated upon in RALS and n 40 LS groups that will be age sex BMI and pre-operative risk score matched
Surgical procedure and overall study design Data will be collected during index procedures For example prostatectomy or anterior resection using either RALS or LS Before surgery surgeons are fitted with both EMG to measure muscle fatigue and EEG to measure cognitive fatigue Surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strainpain and cognitive fatigue
This research is being conducted in real-life surgery and controlling conditions between operations is uniquely challenging The study will exclude any operations where complications result in the surgery taking beyond 50 of the mean average surgery time to prevent this skewing the data towards an effect for musculoskeletal fatigue This mean average time will also include for specific procedures eg Prostatectomy - defining resection margins by dissecting the endopelvic fascia and mobilising seminal vesicles rectum and bladder neck defining and transecting the prostatic pedicles transecting the bladder neck urethra and prostate anastomosing the urethra to bladder neck Bowel surgery - identifying transecting and ligating the pedicle lateral mobilisation and preserving ureters and bowel anastomosis
The investigators will assess acute fatigue by comparing RALS and LS within a single surgery that is the first surgery of any given day To determine the cumulative fatigue chronic effects of surgery aim 2 comparison will be made between the subjects first and last surgery of the day when 2 surgeries have been completed
Measurement of musculoskeletal fatigue EMG EMG justification The study will utilise electromyography EMG to determine acute and chronic changes in musculoskeletal demands associated with RALS and LS surgery Surface EMG is a non-invasive procedure that measures muscle activity by recording the electrical signal generated during muscle fibre recruitment Its ability to assess fatigue has been long established eg 4 and it has been widely used in many populations including athletes eg 5 dentists 6 and surgeons eg 78 EMG will be collected for 200 s 9 at 0 30 60 90 and 120 minutes of a 2-hour surgical procedure In addition to these time points EMG data will be collected during clinically important tasks eg suturing upon completion of surgery which typically will take 10 minutes
EMG protocol Surgeons will provide written informed consent prior to participation Surgeons will be completing index procedures For example prostatectomy or anterior resection using either RALS or LS the protocol for EMG data collection will be identical Before surgery surgeons will be fitted with wireless EMG sensors The EMG data collection procedures will follow established protocols regarding site preparation and electrode placement as well as data collection processing and normalisation 712 Briefly the site will be shaved and cleansed with alcohol wipes with the bipolar electrodes placed on the belly of the muscle and parallel to the muscles fibres having an inter-electrode distance of 20mm 12 Electrodes will be placed on muscles of the arm neck shoulder and back eg flexor carpi radialis muscles biceps muscle bilaterally from the trapezius muscles and bilaterally from the erector spinae muscle These muscles have been selected based on a recent meta-analysis 13 Electrodes are fitted before surgeons scrub for surgery and electrodes will be covered by surgical gowns thereby maintaining a sterile theatre A wireless EMG system has been selected so that it is minimally invasive and does not impede a surgeons movement with wires
EMG data analysis Data will be collected and analysed using EMG Works Delsys Inc Boston MA USA with recommended normalisation sampling filtering and smoothing techniques 7 EMG recordings in previous data show significant changes during LS procedures in 70 - 85 of surgeons mainly in neck shoulders hands lower back and lower extremities muscles The recordings from muscles of the arm neck shoulder and back will be monitored but lower limb muscles will not be included because during RALS Surgeons are seated away from the patient and having brow- and armrests considerably modifies the workload on the lower limbs making comparisons of lower-limb muscles in LS not meaningful Once the EMG signal has been normalised 10 basic EMG variables such as frequency and amplitude can provide information on how muscle fibre recruitment has changed both at a single muscle as well across several muscles activation recruitment strategies while a fatigue score can also be calculated 11 The normalisation process can afford the ability to compare between muscles as well as examine the muscles activity different time points ie within the same session or after a longer time has elapsed eg 51213
Measurement of cognitive fatigue EEG EEG justification The study will use electroencephalography EEG to determine if acute or chronic changes in musculoskeletal demands are associated with changes in motor control and cognitive fatigue Cognitive fatigue can be determined via neurophysiological measures such as the electroencephalogram The EEG can measure the ongoing electrical activity of the brain during a given task such as whilst driving or during surgery EEG measures of fatigue can provide an objective quantification of an individuals cognitive state in real-time removing reliance on subjective measures such as self-report or questionnaires that have been found to be unreliable for moderate fatigue states The brain oscillates at a number of different frequencies at any given time and this information is recorded in the EEG The power of certain frequency bands has been taken as a proxy to index cognitive fatigue Specifically evidence indicates that alpha-band power 7-13 Hz is sensitive to fatigue for a review see 14 and has been used to measure driver fatigue both in real-traffic and simulation exercises 15- 18 When fatigue increases alpha-band activity occurs in bursts of 500 milliseconds which are known as alpha spindles 19 Alpha spindles are considered to reflect individual fatigue states and can be quantified in terms of their peak frequency duration and amplitude giving rise to an individuals alpha signature 20
EEG protocol Whilst surgeons are having EMG electrodes fitted a similar procedure will be completed for the wireless EEG electrodes The skin site on the head will be prepared as previously described 21 and the electrode gel and electrode cap will be applied before the surgical cap thereby maintaining the sterility of the surgical theatre Electrodes will be placed over the cortex using an 8-channel electrode montage to record ongoing EEG oscillations during surgery for 200 s 9 at 0 30 60 90 and 120 minutes of a 2-hour surgical procedure Electrodes will be positioned according to the 10-20 international electrode placement system The main EEG channels of interest will be positioned over the occipital and parietal cortex namely electrode locations O1 O2 P3 P4 P7 P8 where maximal alpha activity can be detected In addition to these time points EEG data will be collected during clinically important tasks eg suturing upon completion of surgery which typically will take 10 minutes A wireless EEG system has been selected so that it is minimally invasive and does not cause distraction or restriction due to movement of wires
EEG data analysis Data will be collected and analysed using Enobio 8 5G Neuroelectrics Cambridge MA USA using standard referencing sampling filtering and smoothing techniques 21 Investigators will compare peak alpha power and alpha spindle duration and amplitude in RALS compared to LS Changes in EEG power spectra specifically in the alpha frequency band will be used to monitor alertness and will provide crucial information about whether cognitive fatigue underpins any musculoskeletal fatigue The study will also be able to identify how alertness changes over time during surgery through the EEG power spectra
Measurements of surgeon physical activity and musculoskeletal health It is vital that musculoskeletal fatigue in the surgeons is not influenced by anything other than the work environment We will use tri-axial accelerometery every week throughout data collection to measure and ensure surgeons are not changing their physical activity patterns and thus getting stronger or weaker Nutrition is also critical in the development of strength just like poor nutrition can lead to strength loss Therefore surgeons will complete 3-day food diaries and dietary analysis at weekly intervals throughout the data collection period
Statistics and data analysis Power calculation To address aim 1 The investigators anticipate a difference in musculoskeletal fatigue of 20 between RALS and LS based upon the limited evidence available 1 Therefore based on a predicted effect size Cohens d of 082 recruitment of 40 subjects in RALS and 40 subjects in LS total sample size n 80 will be carried out These numbers will be matched between prostate and bowel surgeries In aim 2 data suggest that the level of fatigue between the last surgery of the day versus the first will be greater than the difference in aim 1 Cohens d 090 therefore 27 subjectsgroup are required for this research question Lastly in aim 3 to investigate whether changes in musculoskeletal fatigue are underpinned by changes in motor control and cognitive fatigue The investigators anticipate an effect size of 085 between RALS and LS and therefore will use data from the 31group to study this effect An A priori power calculation will be used to compute the required sample size using GPower 3 22 Conservatively the lower of the three values for the power calculation an effect size of 082 has been chosen Assuming a Cohens d of 082 requires 40 participants per group for 90 power to detect a difference between groups at an alpha of 005
Statistical analysis To determine differences in musculoskeletal and cognitive fatigue in RALS and LS a mixed-model ANOVA or non-parametric equivalent will be utilised The data and conclusions arrived at the end of the study will inform recommendations both in scientific literature publications and dissemination at conferences towards the end of the project see Gantt chart The study is the platform to develop a strong case regarding the long-term musculoskeletal effects on surgeons performing minimal access procedures in RALS
According to the Office for National Statistics in the UK musculoskeletal problems amongst the workforce are the second most common cause for absence 177 and account for 23 days absenceyear 2 This is not dissimilar in the US where the Bureau of Labour Statistics estimates that 62 of all worker injuries and 32 of missed days from work result from musculoskeletal problems Collectively these data suggest that musculoskeletal problems caused by careers in surgery can reduce physical health which is associated with reduced productivity career longevity and even the quality of patient care
Robotic-assisted laparoscopic surgery RALS is a modern technology that could help mitigate these musculoskeletal problems and thereby improve patient care In comparison to standard laparoscopic surgery LS RALS offers steadier wrist movements with a reduced fulcrum effect thus benefiting the patient 3 There is emerging evidence that RALS is associated with a lower rate of musculoskeletal problems 23-80 than LS 70- 100 1 RALS may therefore be an attractive alternative to LS despite the high cost of equipment and steep learning curve during training
No study has compared the demands of RALS vs LS on musculoskeletal fatigue and subsequent injury risk and whether these changes are underpinned by changes in cognitive fatigue The investigators aim to determine whether a career using RALS is associated with better musculoskeletal health for surgeons than standard LS when performing complex minimally invasive procedures
The hypothesis is that RALS will reduce musculoskeletal fatigue and the prevalence of musculoskeletal injury in surgeons compared to LS If this is true RALS should receive increased support through preserving surgeons health and thereby reducing costs for healthcare providers
Research subjects surgeons and patients Surgeons Investigators will recruit surgeons completing surgical procedures who have similar levels of experience between RALS and LS groups Surgeons will fill a questionnaire regarding working hours and experience physical activity level eg sport bicycling to work or gardening general health conditions and musculoskeletal symptoms within the last 12 months using the Standardized Nordic questionnaires for the analysis of musculoskeletal symptoms 11 The investigators will also quantify body composition height body weight BMI muscle mass fat mass using clinically-validated bioelectrical impedance analysis Surgeons will broadly be matched for age and surgical experience anthropometry and sex Patients To complete the work the investigators will use data from n 40 patients being operated upon in RALS and n 40 LS groups that will be age sex BMI and pre-operative risk score matched
Surgical procedure and overall study design Data will be collected during index procedures For example prostatectomy or anterior resection using either RALS or LS Before surgery surgeons are fitted with both EMG to measure muscle fatigue and EEG to measure cognitive fatigue Surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strainpain and cognitive fatigue
This research is being conducted in real-life surgery and controlling conditions between operations is uniquely challenging The study will exclude any operations where complications result in the surgery taking beyond 50 of the mean average surgery time to prevent this skewing the data towards an effect for musculoskeletal fatigue This mean average time will also include for specific procedures eg Prostatectomy - defining resection margins by dissecting the endopelvic fascia and mobilising seminal vesicles rectum and bladder neck defining and transecting the prostatic pedicles transecting the bladder neck urethra and prostate anastomosing the urethra to bladder neck Bowel surgery - identifying transecting and ligating the pedicle lateral mobilisation and preserving ureters and bowel anastomosis
The investigators will assess acute fatigue by comparing RALS and LS within a single surgery that is the first surgery of any given day To determine the cumulative fatigue chronic effects of surgery aim 2 comparison will be made between the subjects first and last surgery of the day when 2 surgeries have been completed
Measurement of musculoskeletal fatigue EMG EMG justification The study will utilise electromyography EMG to determine acute and chronic changes in musculoskeletal demands associated with RALS and LS surgery Surface EMG is a non-invasive procedure that measures muscle activity by recording the electrical signal generated during muscle fibre recruitment Its ability to assess fatigue has been long established eg 4 and it has been widely used in many populations including athletes eg 5 dentists 6 and surgeons eg 78 EMG will be collected for 200 s 9 at 0 30 60 90 and 120 minutes of a 2-hour surgical procedure In addition to these time points EMG data will be collected during clinically important tasks eg suturing upon completion of surgery which typically will take 10 minutes
EMG protocol Surgeons will provide written informed consent prior to participation Surgeons will be completing index procedures For example prostatectomy or anterior resection using either RALS or LS the protocol for EMG data collection will be identical Before surgery surgeons will be fitted with wireless EMG sensors The EMG data collection procedures will follow established protocols regarding site preparation and electrode placement as well as data collection processing and normalisation 712 Briefly the site will be shaved and cleansed with alcohol wipes with the bipolar electrodes placed on the belly of the muscle and parallel to the muscles fibres having an inter-electrode distance of 20mm 12 Electrodes will be placed on muscles of the arm neck shoulder and back eg flexor carpi radialis muscles biceps muscle bilaterally from the trapezius muscles and bilaterally from the erector spinae muscle These muscles have been selected based on a recent meta-analysis 13 Electrodes are fitted before surgeons scrub for surgery and electrodes will be covered by surgical gowns thereby maintaining a sterile theatre A wireless EMG system has been selected so that it is minimally invasive and does not impede a surgeons movement with wires
EMG data analysis Data will be collected and analysed using EMG Works Delsys Inc Boston MA USA with recommended normalisation sampling filtering and smoothing techniques 7 EMG recordings in previous data show significant changes during LS procedures in 70 - 85 of surgeons mainly in neck shoulders hands lower back and lower extremities muscles The recordings from muscles of the arm neck shoulder and back will be monitored but lower limb muscles will not be included because during RALS Surgeons are seated away from the patient and having brow- and armrests considerably modifies the workload on the lower limbs making comparisons of lower-limb muscles in LS not meaningful Once the EMG signal has been normalised 10 basic EMG variables such as frequency and amplitude can provide information on how muscle fibre recruitment has changed both at a single muscle as well across several muscles activation recruitment strategies while a fatigue score can also be calculated 11 The normalisation process can afford the ability to compare between muscles as well as examine the muscles activity different time points ie within the same session or after a longer time has elapsed eg 51213
Measurement of cognitive fatigue EEG EEG justification The study will use electroencephalography EEG to determine if acute or chronic changes in musculoskeletal demands are associated with changes in motor control and cognitive fatigue Cognitive fatigue can be determined via neurophysiological measures such as the electroencephalogram The EEG can measure the ongoing electrical activity of the brain during a given task such as whilst driving or during surgery EEG measures of fatigue can provide an objective quantification of an individuals cognitive state in real-time removing reliance on subjective measures such as self-report or questionnaires that have been found to be unreliable for moderate fatigue states The brain oscillates at a number of different frequencies at any given time and this information is recorded in the EEG The power of certain frequency bands has been taken as a proxy to index cognitive fatigue Specifically evidence indicates that alpha-band power 7-13 Hz is sensitive to fatigue for a review see 14 and has been used to measure driver fatigue both in real-traffic and simulation exercises 15- 18 When fatigue increases alpha-band activity occurs in bursts of 500 milliseconds which are known as alpha spindles 19 Alpha spindles are considered to reflect individual fatigue states and can be quantified in terms of their peak frequency duration and amplitude giving rise to an individuals alpha signature 20
EEG protocol Whilst surgeons are having EMG electrodes fitted a similar procedure will be completed for the wireless EEG electrodes The skin site on the head will be prepared as previously described 21 and the electrode gel and electrode cap will be applied before the surgical cap thereby maintaining the sterility of the surgical theatre Electrodes will be placed over the cortex using an 8-channel electrode montage to record ongoing EEG oscillations during surgery for 200 s 9 at 0 30 60 90 and 120 minutes of a 2-hour surgical procedure Electrodes will be positioned according to the 10-20 international electrode placement system The main EEG channels of interest will be positioned over the occipital and parietal cortex namely electrode locations O1 O2 P3 P4 P7 P8 where maximal alpha activity can be detected In addition to these time points EEG data will be collected during clinically important tasks eg suturing upon completion of surgery which typically will take 10 minutes A wireless EEG system has been selected so that it is minimally invasive and does not cause distraction or restriction due to movement of wires
EEG data analysis Data will be collected and analysed using Enobio 8 5G Neuroelectrics Cambridge MA USA using standard referencing sampling filtering and smoothing techniques 21 Investigators will compare peak alpha power and alpha spindle duration and amplitude in RALS compared to LS Changes in EEG power spectra specifically in the alpha frequency band will be used to monitor alertness and will provide crucial information about whether cognitive fatigue underpins any musculoskeletal fatigue The study will also be able to identify how alertness changes over time during surgery through the EEG power spectra
Measurements of surgeon physical activity and musculoskeletal health It is vital that musculoskeletal fatigue in the surgeons is not influenced by anything other than the work environment We will use tri-axial accelerometery every week throughout data collection to measure and ensure surgeons are not changing their physical activity patterns and thus getting stronger or weaker Nutrition is also critical in the development of strength just like poor nutrition can lead to strength loss Therefore surgeons will complete 3-day food diaries and dietary analysis at weekly intervals throughout the data collection period
Statistics and data analysis Power calculation To address aim 1 The investigators anticipate a difference in musculoskeletal fatigue of 20 between RALS and LS based upon the limited evidence available 1 Therefore based on a predicted effect size Cohens d of 082 recruitment of 40 subjects in RALS and 40 subjects in LS total sample size n 80 will be carried out These numbers will be matched between prostate and bowel surgeries In aim 2 data suggest that the level of fatigue between the last surgery of the day versus the first will be greater than the difference in aim 1 Cohens d 090 therefore 27 subjectsgroup are required for this research question Lastly in aim 3 to investigate whether changes in musculoskeletal fatigue are underpinned by changes in motor control and cognitive fatigue The investigators anticipate an effect size of 085 between RALS and LS and therefore will use data from the 31group to study this effect An A priori power calculation will be used to compute the required sample size using GPower 3 22 Conservatively the lower of the three values for the power calculation an effect size of 082 has been chosen Assuming a Cohens d of 082 requires 40 participants per group for 90 power to detect a difference between groups at an alpha of 005
Statistical analysis To determine differences in musculoskeletal and cognitive fatigue in RALS and LS a mixed-model ANOVA or non-parametric equivalent will be utilised The data and conclusions arrived at the end of the study will inform recommendations both in scientific literature publications and dissemination at conferences towards the end of the project see Gantt chart The study is the platform to develop a strong case regarding the long-term musculoskeletal effects on surgeons performing minimal access procedures in RALS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None