Surgical FatigueNCT06978309
EMG Response in Forearm and Neck Muscles When Comparing Surgical Techniques.
An observational study of Surgical Fatigue, run by Lancaster University at 1 site in United Kingdom.
Trial summary
Surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. However, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related Musculoskeletal (MSK) injuries… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Fatigue
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2025to 8 Sep 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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
Study population: Healthy, adult laparoscopic and robot- assisted laparoscopic surgeons.
Who may be able to join
- Either a laparoscopic or robot-assisted laparoscopic surgeon.
- Good musculoskeletal health.
- Adult.
Who cannot join
- Procedures with major complications (above 50% more time than the average for that surgery).
- Significant co- morbidities that could affect the results of the study. Significant symptoms of musculoskeletal disorder.
- Anything the investigator feels will affect the study's measurements of safety.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blackburn Royal Teaching Hospital
Blackburn, Lancashire
About this study
Official title: Exploring the Difference in EMG Response of Forearm and Sternocleidomastoid Muscles When Comparing Laparoscopic Surgery (LS) and Robot Assisted Laparoscopic Surgery (RALS).
Surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. However, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related Musculoskeletal (MSK) injuries amongst surgeons. Work-related MSK disorders account for 26 - 47.5% of illnesses and injuries due to overexertion and repetitive use, in professionals with ergonomically challenging jobs. Robotic-assisted laparoscopic surgery (RALS) is a modern technology that could help mitigate these MSK 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.
No study has compared the demands of RALS vs. LS on musculoskeletal fatigue (and subsequent injury risk). The investigators need to determine whether a career using RALS is associated with better musculoskeletal health of surgeons than standard LS when performing complex minimally invasive procedures.
Read more
The study will recruit Surgeons who perform prostate and bowel surgical procedures who have experience using RALS and/or LS. Surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strain/pain and will have body composition quantified.
They will be fitted with EMG (to measure muscle fatigue) whilst performing real-life surgery. Analysis of data gathered will be used to show what the short- and long- term musculoskeletal demands are and in turn determine if these are associated with changes in motor control.
The researcher's postulated hypothesis is that RALS should have less musculoskeletal effects both short and long term on surgeons, therefore, highlighting the fact that the implementation of RALS should be less controversial, because in the long run, the most expensive objects in the operating room are the personnel.
- Conditions
- Surgical Fatigue
- Being tested
- No Interventions
- Keywords
- fatigue, Laparoscopic, Surgeon wellbeing, Robotic surgery, EMG
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
Observational study.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Laparoscopic Surgery | Surgeons performing robot assisted laparoscopic surgery. Receives: Other: No Interventions | |
| Laparoscopic Surgery | Surgeons performing manual laparoscopic surgery. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency.
This outcome measures the immediate impact of RALS and LS on the surgeon's forearm muscles during a single surgical procedure. It will be quantified by assessing the change in electromyography (EMG) frequency and amplitude recorded during clinically important surgical tasks within the surgeons' first surgery of the day. The contributing measures to this primary measure are the maximal voluntary contraction that will be assessed just before the surgery begins, and the average frequency of muscle activation (mV) over the 2 minute data collection period. Muscle activation for RALS and LS will be compared using this measure.
Measured: Intraoperative
Secondary outcomes (8)
Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
This questionnaire assesses musculoskeletal symptoms experienced by the surgeons within the last 12 months. It helps to understand the prevalence and location of pain and discomfort before they participate in the study. This questionnaire primarily yields categorical data. For each of the nine body regions (neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees, ankles/feet), it asks about trouble (ache, pain, discomfort) in the past 12 months and in the past 7 days. It also asks if the trouble prevented normal work (at home or away from home).
Measured: Preoperative
Surgeon physical activity participation status (International Physical Activity Questionnaire
The frequency, duration, and intensity of different types of physical activities (vigorous, moderate, walking, and sitting) undertaken by the surgeons. It aims to quantify their overall physical activity level. Can be reported as continuous scores (Metabolic Equivalent of Task - minutes per week, or MET-min/week) calculated by multiplying duration, frequency, and standard MET intensity values for each activity type. It can also be categorized into low, moderate, and high physical activity levels based on specific criteria related to frequency, duration, and total MET-min/week.
Measured: Preoperative
Surgeon well-being and quality of life (SF36 Health and Wellbeing Questionnaire)
This assesses the surgeon's health-related quality of life across eight dimensions: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, General Health Perceptions, Vitality (energy/fatigue), Social Functioning, Role Limitations due to Emotional Problems,1 and Mental Health (emotional well-being). This yields eight scaled scores ranging from 0 to 100, with higher scores indicating better health status in each dimension. Scoring involves recoding items, summing within scales, and then transforming to the standardized range using specific algorithms. Summary scores (PCS and MCS) can also be calculated.
Measured: Preoperative
Maximal Voluntary Contraction measured using EMG (mV)
This will take place with the surgeon producing the a maximal contraction for both their forearm muscles and neck muscles in to create a baseline of comparison to calculate the percentage of maximal contraction that the surgeons experience during surgery.
Measured: Intraoperative
Acute muscle activation- percentage of sternocleidomastoid maximal voluntary contraction (%) assesed using EMG frequency.
This outcome measures the immediate impact of RALS and LS on the surgeon's sternocleidomastoid muscles during a single surgical procedure. It will be quantified by assessing the change in electromyography (EMG) frequency and amplitude recorded during clinically important surgical tasks within the surgeons' first surgery of the day. The contributing measures to this primary measure are the maximal voluntary contraction that will be assessed just before the surgery begins, and the average frequency of muscle activation (mV) over the 2 minute data collection period. Muscle activation for RALS and LS will be compared using this measure.
Measured: Intraoperative
Average sternocleidomastoid and forearm muscle EMG amplitude (mV)
This will be measured using EMG at clinically significant points in the surgery. This will allow for the researchers to assess the muscular demand and the amplitude and frequency of the EMG signal are the direct measures used to quantify this primary variable. Lower amplitude means a greater muscular demand.
Measured: Intraoperative
Average sternocleidomastoid and forearm muscle EMG frequency (Hz).
This will be measured using EMG at clinically significant points in the surgery. This will allow for the researchers to assess the muscular demand and the amplitude and frequency of the EMG signal are the direct measures used to quantify this primary variable. Higher frequency means greater muscular demand.
Measured: Intraoperative
Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
This questionnaire assesses musculoskeletal symptoms experienced by the surgeons within the last 12 months. It helps to understand the prevalence and location of pain and discomfort before they participate in the study. This questionnaire primarily yields categorical data. For each of the nine body regions (neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees, ankles/feet), it asks about trouble (ache, pain, discomfort) in the past 12 months and in the past 7 days. It also asks if the trouble prevented normal work (at home or away from home).
Measured: Any time between enrolment in the study and the date of the surgical procedure that the data collection will take place.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start6 May 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical FatigueStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Davitt, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978309
- Sponsor's protocol ID
- FHM-2025-4948-IRAS-2
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only IPD in the published results will potentially be included.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Difference in EMG Response of Forearm and Sternocleidomastoid Muscles When Comparing Laparoscopic Surgery (LS) and Robot Assisted Laparoscopic Surgery (RALS).
- ClinicalTrials.gov ID
- NCT06978309
- Acronym / sponsor ID
- FHM-2025-4948-IRAS-2
- Conditions
- Surgical Fatigue
- Keywords
- fatigue, Laparoscopic, Surgeon wellbeing, Robotic surgery, EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 18 May 2025 (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.
Surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. However, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related Musculoskeletal (MSK) injuries amongst surgeons. Work-related MSK disorders account for 26 - 47.5% of illnesses and injuries due to overexertion and repetitive use, in professionals with ergonomically challenging jobs. Robotic-assisted laparoscopic surgery (RALS) is a modern technology that could help mitigate these MSK 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.
No study has compared the demands of RALS vs. LS on musculoskeletal fatigue (and subsequent injury risk). The investigators need to determine whether a career using RALS is associated with better musculoskeletal health of surgeons than standard LS when performing complex minimally invasive procedures.
The study will recruit Surgeons who perform prostate and bowel surgical procedures who have experience using RALS and/or LS. Surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strain/pain and will have body composition quantified.
They will be fitted with EMG (to measure muscle fatigue) whilst performing real-life surgery. Analysis of data gathered will be used to show what the short- and long- term musculoskeletal demands are and in turn determine if these are associated with changes in motor control.
The researcher's postulated hypothesis is that RALS should have less musculoskeletal effects both short and long term on surgeons, therefore, highlighting the fact that the implementation of RALS should be less controversial, because in the long run, the most expensive objects in the operating room are the personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Laparoscopic Surgery | – | Other: No InterventionsSurgeons performing robot assisted laparoscopic surgery. |
| Laparoscopic Surgery | – | Other: No InterventionsSurgeons performing manual laparoscopic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, adult laparoscopic and robot- assisted laparoscopic surgeons.
Key inclusion criteria (3 listed)
- Either a laparoscopic or robot-assisted laparoscopic surgeon.
- Good musculoskeletal health.
- Adult.
Key exclusion criteria (3 listed)
- Procedures with major complications (above 50% more time than the average for that surgery).
- Significant co- morbidities that could affect the results of the study. Significant symptoms of musculoskeletal disorder.
- Anything the investigator feels will affect the study's measurements of safety.
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 |
|---|---|---|
| No InterventionsObservational study. | Other | Laparoscopic Surgery, Robot-Assisted Laparoscopic Surgery |
Primary outcome
Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency.
Time frame: Intraoperative
This outcome measures the immediate impact of RALS and LS on the surgeon's forearm muscles during a single surgical procedure. It will be quantified by assessing the change in electromyography (EMG) frequency and amplitude recorded during clinically important surgical tasks within the surgeons' first surgery of the day. The contributing measures to this primary measure are the maximal voluntary contraction that will be assessed just before the surgery begins, and the average frequency of muscle activation (mV) over the 2 minute data collection period. Muscle activation for RALS and LS will be compared using this measure.
8 secondary outcomes
Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
Time frame: Preoperative
Surgeon physical activity participation status (International Physical Activity Questionnaire
Time frame: Preoperative
Surgeon well-being and quality of life (SF36 Health and Wellbeing Questionnaire)
Time frame: Preoperative
Maximal Voluntary Contraction measured using EMG (mV)
Time frame: Intraoperative
Acute muscle activation- percentage of sternocleidomastoid maximal voluntary contraction (%) assesed using EMG frequency.
Time frame: Intraoperative
Average sternocleidomastoid and forearm muscle EMG amplitude (mV)
Time frame: Intraoperative
Average sternocleidomastoid and forearm muscle EMG frequency (Hz).
Time frame: Intraoperative
Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
Time frame: Any time between enrolment in the study and the date of the surgical procedure that the data collection will take place.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. Only IPD in the published results will potentially be included.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Fatigue, run by Lancaster University 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 26 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency. (time frame: Intraoperative). 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 26 Jan 2026.