NCT06978309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

April 23, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

fatigueLaparoscopicSurgeon wellbeingRobotic surgeryEMG

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intraoperative

Secondary Outcomes (8)

  • Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)

    Preoperative

  • Surgeon physical activity participation status (International Physical Activity Questionnaire

    Preoperative

  • Surgeon well-being and quality of life (SF36 Health and Wellbeing Questionnaire)

    Preoperative

  • Maximal Voluntary Contraction measured using EMG (mV)

    Intraoperative

  • Acute muscle activation- percentage of sternocleidomastoid maximal voluntary contraction (%) assesed using EMG frequency.

    Intraoperative

  • +3 more secondary outcomes

Study Arms (2)

Robot-Assisted Laparoscopic Surgery

Surgeons performing robot assisted laparoscopic surgery.

Other: No Interventions

Laparoscopic Surgery

Surgeons performing manual laparoscopic surgery.

Other: No Interventions

Interventions

Observational study.

Laparoscopic SurgeryRobot-Assisted Laparoscopic Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, adult laparoscopic and robot- assisted laparoscopic surgeons.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blackburn Royal Teaching Hospital

Blackburn, Lancashire, United Kingdom

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 18, 2025

Study Start

May 6, 2025

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations