Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT06938958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ergonomic Challenges for Surgeons; The Problem and Solutions
Sponsor:
Organization:
Raw JSON
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Despite growing awareness, there remains a lack of detailed data on the specific postures that contribute to ergonomic risk, particularly within General Surgery. This study aims to characterise postures encountered during open, laparoscopic, and robotic gastrointestinal procedures using wearable sensor technology and video analysis, to inform future ergonomic interventions and training.\n\nA single-centre, prospective observational study of 30 surgical cases will be conducted at University Hospitals Plymouth NHS Trust. Participating surgeons will wear inertial measurement units (IMUs) to record real-time body segment position data whilst performing live surgery. A biomechanical model will then be used to calculate joint angles and whole body posture. Video recordings will be synchronised with IMU data to map posture to surgical tasks. Static and dynamic postures will be analysed using standard ergonomic assessment tools. Alternative tools tailored to surgery will be assessed and proposed. Surgeons will complete questionnaires pre- and post-operatively to report musculoskeletal symptoms. Outcomes will compare ergonomic risk across surgical techniques, identify high-risk procedural steps, and assess the acceptability of wearable technologies in the operating theatre. The data generated will also be used to evaluate, train or refine artificially intelligent camera-based pose estimation models for the operating theatre environment in order to make future ergonomics research and assessment more accessible.', 'detailedDescription': "Surgeons often spend long hours in physically demanding positions, which can lead to work-related musculoskeletal disorders (WMSDs) such as neck, shoulder, and back pain. These issues can impact a surgeon's well-being, career longevity, and surgical performance. This study aims to understand the ergonomic challenges surgeons face during major gastrointestinal (GI) surgeries, including open, laparoscopic (keyhole), and robotic procedures. By analysing their posture during operations, researchers hope to develop strategies to reduce the risk of injury.\n\nThe study will recruit general surgeons from University Hospitals Plymouth NHS Trust who perform or assist in GI surgeries. Using small motion sensors (Inertial Measurement Units, or IMUs) placed on the surgeons' bodies, researchers will track joint movements, body positions, and posture throughout different surgical techniques. This will help identify which postures and surgical steps are associated with the highest ergonomic risk. Video recordings of surgeries will also be collected to analyse movements and develop future training tools.\n\nSurgeons will complete questionnaires before and after surgery to report any discomfort or pain. The study will compare different surgical techniques to determine which carries the highest risk of injury and which aspects of surgery contribute to poor ergonomics.\n\nBy identifying high-risk postures and steps within procedures, this research aims to provide recommendations for ergonomic improvements, such as better training, surgical workstation adjustments, or new tools to help surgeons maintain healthier postures. The results could lead to improved surgeon well-being, safer surgical practices, and longer career sustainability. Findings from this study will be used to develop educational materials and future research in surgical ergonomics.\n\nThis study is observational and does not require any changes to standard surgical practice. Both surgeons and patients will provide consent before participation, ensuring ethical research practices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surgeons Performing Major Upper GI Surgery at University Hosptials Plymouth NHS Trust', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgeons performing gastro-intestinal (GI) surgery\n* Surgeons assisting GI surgery\n* Open, laparoscopic and robotic GI operation\n* Informed consent from surgeon\n* Informed consent from patient\n\nExclusion Criteria:\n\n* Pre-existing severe practice-limiting musculoskeletal disorder\n* Surgeon not consenting to participation\n* Patient not consenting to participation'}, 'identificationModule': {'nctId': 'NCT06938958', 'briefTitle': 'Ergonomic Challenges for Surgeons; The Problem and Solutions', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'Characterisation of the Postures Encountered During Surgery and Development of Strategies to Reduce the Risk of Developing Work-related Musculoskeletal Disorders in Surgeons', 'orgStudyIdInfo': {'id': '24WBG122'}, 'secondaryIdInfos': [{'id': '350363', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Video and Motion Analysis', 'type': 'OTHER', 'description': '1. Measurements of joint angle, body segment position, static and dynamic postures and posture duration.\n2. Video of Surgeon and Procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'contacts': [{'name': 'Alexander Bush, BMBS', 'role': 'CONTACT', 'email': 'alexander.bush@nhs.net', 'phone': '07979786599'}], 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'centralContacts': [{'name': 'Alexander Bush, MBBS', 'role': 'CONTACT', 'email': 'alexander.bush@nhs.net', 'phone': '01752 202082'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'An anonymised video and motion data library will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Plymouth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}