Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection
ENDERGO
1 other identifier
interventional
10
1 country
1
Brief Summary
The prevalence of musculoskeletal disorders (MSDs) among endoscopists is estimated between 29 and 89%. The most common disorders are carpal tunnel syndrome, De Quervain tenosynovitis, lateral epicondylitis and neck pain. Factors associated with MSD among gastroenterologists practicing endoscopy are: the high number of procedures (more than 20/week), the procedure time (more than 16 hours/week) and the number of years of practice.With the evolution of digestive endoscopy superficial cancer can endoscopically be removed by endoscopic submucosal dissection (ESD) avoiding surgical resections. The number of procedures is increasing, with longer examination times in case of ESD (about 2 hours). This volume of hours and procedures may in the near future further increase the risk of MSDs in the population of gastroenterologists. Some good practice recommendations have been proposed to improve practitioner comfort, similar to what is recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a seat during the procedure. There is little data on the biomechanical forced experienced by an endoscopist when performing endoscopy and colonoscopy, and none when performing ESD. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during an ESD the practice of submucosal dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2024
CompletedFirst Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
January 16, 2026
January 1, 2026
2.1 years
August 8, 2024
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
variation of muscle angular during submucosal dissection
day 1
Interventions
Performing endoscopic examinations in the conventional framework of patient follow-up. No patient data is collected. The physician performing the act is the subject of the study.
Eligibility Criteria
You may qualify if:
- Adult subject (age ≥ 18 years)
- hepato-gastroenterologist
- hepato-gastroenterologist performing endoscopic submucosal dissection
- Person who has given consent for participation in the study
You may not qualify if:
- non hepato-gastroenterologist
- Person who has not given consent for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire, Amienslead
- Hospices Civils de Lyoncollaborator
- University Hospital, Lillecollaborator
- Rennes University Hospitalcollaborator
Study Sites (1)
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80000, France
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start
July 11, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share