A Validation Study of a Computerized Movement Analysis of the Colonoscope in Simulated Colonoscopy

NCT03401723 | Completed

• 1 other identifier: 3D-CoPS and 3D-CoRS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope. 24 physicians are recruited and divided based on experience (novices and experienced). All participants are to perform twice on the ETS that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. The movement of the colonoscope will be gathered during the tasks and correlated to the scores of the ETS.

Conditions

Education

Keywords

Validation study; Simulation; Endoscopy

Outcome Measures

Primary Outcomes (2)

• 3D-Colonoscopy Progression Score

  The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.

  3 months

• 3D-Colonoscopy Retraction Score

  The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.

  3 months

Secondary Outcomes (1)

• Relationship to other variables

  3 months

Study Arms (2)

Novices

OTHER

Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies. Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.

Other: 3D-Colonoscopy Progression Score; Other: Endoscopy Training System; Other: 3D-Colonoscopy Retraction Score

Experienced

OTHER

Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists. Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.

Other: 3D-Colonoscopy Progression Score; Other: Endoscopy Training System; Other: 3D-Colonoscopy Retraction Score

Interventions

3D-Colonoscopy Progression Score OTHER

3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

Also known as: 3D-CoPS

Experienced; Novices

Endoscopy Training System OTHER

The Endoscopy Training System is based on the Colonoscopy Training Model platform and includes four different performance metrics and a scoring system. 1. Scope Manipulation - The use of torque and tip deflection to move a shape in the colon 2. Tool Targeting - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched. 3. Loop Management - The management of a standard alfa-loop. 4. Mucosal Inspection - Randomly placed polyps inside the rubber colon have to be found during withdrawal.

Also known as: ETS

Experienced; Novices

3D-Colonoscopy Retraction Score OTHER

3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

Also known as: 3D-CoRS

Experienced; Novices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians

You may not qualify if:

• Non physicians

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Technical University of Denmark: collaborator

Study Sites (1)

Copenhagen Acedemy of Medical Education and Simulation

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Ritter EM, Cox TC, Trinca KD, Pearl JP. Simulated Colonoscopy Objective Performance Evaluation (SCOPE): a non-computer-based tool for assessment of endoscopic skills. Surg Endosc. 2013 Nov;27(11):4073-80. doi: 10.1007/s00464-013-3063-8. Epub 2013 Jul 17.

  PMID: 23860607 BACKGROUND

• Trinca KD, Cox TC, Pearl JP, Ritter EM. Validity evidence for the Simulated Colonoscopy Objective Performance Evaluation scoring system. Am J Surg. 2014 Feb;207(2):218-25. doi: 10.1016/j.amjsurg.2013.08.026. Epub 2013 Oct 23.

  PMID: 24246259 BACKGROUND

Study Officials

• Lars Konge, Prof

  CAMES-Rigshospitalet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is a vialidation study of a computerized analysis of the colonoscope movements during a simulated procedure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Andreas Slot Vilmann

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 17, 2018
• Study Start: December 1, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 30, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)