- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06549894
Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection (ENDERGO)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80000
- Centre Hospitalier Universitaire d'Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult subject (age ≥ 18 years)
- hepato-gastroenterologist
- hepato-gastroenterologist performing endoscopic submucosal dissection
- Person who has given consent for participation in the study
Exclusion Criteria:
- non hepato-gastroenterologist
- Person who has not given consent for participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
variation of muscle angular during submucosal dissection
Time Frame: day 1
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2024_843_0031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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