NCT06938958

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress80%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

April 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 7, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

SurgeonsErgonomicsOROperating RoomOperating TheatreWork Related Musculoskeletal DisordersStrainPostureIMUComputer vision

Outcome Measures

Primary Outcomes (4)

  • Joint angle.

    Joint angles (in degrees)

    During the operative period, from initial incision to final closure.

  • Posture duration.

    The duration of characterised postures (in minutes)

    During the operative period, from incision to closure

  • Posture Variability

    Angles (in degrees/minute)

    During the operative period, from incision to closure

  • Ergonomic Risk

    RULA Score will be calculated

    During the operative period, from incision to closure

Secondary Outcomes (5)

  • Compare open, laparoscopic and robotic techniques

    During the operative period, from incision to closure

  • Compare open, laparoscopic and robotic techniques

    During the operative period, from incision to closure

  • Identify specific surgical procedures which carry high ergonomic risk

    Pre-procedure, immediately post procedure and 24 hours after end of procedure.

  • Create a video library for use in development of educational/training/monitoring tools

    During the operative period, from incision to closure

  • Determine the acceptability of sensor-based methods for recording posture data during GI surgery

    During the operative period, from incision to closure

Interventions

1. Measurements of joint angle, body segment position, static and dynamic postures and posture duration. 2. Video of Surgeon and Procedure.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgeons Performing Major Upper GI Surgery at University Hosptials Plymouth NHS Trust

You may qualify if:

  • Surgeons performing gastro-intestinal (GI) surgery
  • Surgeons assisting GI surgery
  • Open, laparoscopic and robotic GI operation
  • Informed consent from surgeon
  • Informed consent from patient

You may not qualify if:

  • Pre-existing severe practice-limiting musculoskeletal disorder
  • Surgeon not consenting to participation
  • Patient not consenting to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Sprains and Strains

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

Alexander Bush, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 22, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations