Clinical trial NCT04263818: Endoscopist and Endoscope Motions During Colonoscopy
Official title: Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Disease
Colonic Diseases
Keywords: colonoscopy
tracking motion
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

Detailed description: The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patient male or female
* Patient over 18 years old
* Patient who are scheduled for a colonoscopy procedure under sedation
* Patient able to understand the study and provide written informed consent
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient unable to provide a written informed consent
* Patient with an altered colonic anatomy due to previous surgery
* Patient with a known anomaly of the colon
* Patient carrying an implantable medical device (pacemaker...)
* Patient with a condition preventing its participation to study procedures, according to investigator's judgment
* Pregnancy or breastfeeding
* Patient in custody
* Patient under guardianship

Primary outcomes:
measure: Body motions recording
timeFrame: At time of colonoscopy
measure: Endoscope motions recording
timeFrame: At time of colonoscopy
measure: Endoscope wheels rotation recording
timeFrame: At time of colonoscopy
measure: Endoluminal images recording
timeFrame: At time of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
name: Silvana PERRETTA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.