Clinical trial NCT06978309: EMG Response in Forearm and Neck Muscles When Comparing Surgical Techniques.
Official title: Exploring the Difference in EMG Response of Forearm and Sternocleidomastoid Muscles When Comparing Laparoscopic Surgery (LS) and Robot Assisted Laparoscopic Surgery (RALS).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Surgical Fatigue
Keywords: fatigue
Laparoscopic
Surgeon wellbeing
Robotic surgery
EMG
Lead sponsor: Lancaster University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, adult laparoscopic and robot- assisted laparoscopic surgeons.

Brief 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 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.


Eligibility criteria: Inclusion Criteria

* Either a laparoscopic or robot-assisted laparoscopic surgeon.
* Good musculoskeletal health.
* Adult.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency.
timeFrame: Intraoperative
Secondary outcomes:
measure: Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
timeFrame: Preoperative
measure: Surgeon physical activity participation status (International Physical Activity Questionnaire
timeFrame: Preoperative
measure: Surgeon well-being and quality of life (SF36 Health and Wellbeing Questionnaire)
timeFrame: Preoperative
measure: Maximal Voluntary Contraction measured using EMG (mV)
timeFrame: Intraoperative
measure: Acute muscle activation- percentage of sternocleidomastoid maximal voluntary contraction (%) assesed using EMG frequency.
timeFrame: Intraoperative
measure: Average sternocleidomastoid and forearm muscle EMG amplitude (mV)
timeFrame: Intraoperative
measure: Average sternocleidomastoid and forearm muscle EMG frequency (Hz).
timeFrame: Intraoperative
measure: Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)
timeFrame: Any time between enrolment in the study and the date of the surgical procedure that the data collection will take place.
Other outcomes:
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