Viewing Study NCT06938958


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: University Hospital Plymouth NHS Trust
Organization:

Study Overview

Official Title: Characterisation of the Postures Encountered During Surgery and Development of Strategies to Reduce the Risk of Developing Work-related Musculoskeletal Disorders in Surgeons
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-04
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: None
Brief Summary: Work-related musculoskeletal disorders (WMSDs) are highly prevalent among surgeons. 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.

A 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.
Detailed Description: 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.

The 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.

Surgeons 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.

By 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.

This 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.

Study Oversight

Has Oversight DMC: True
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?: False
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
350363 OTHER IRAS View