NCT06101836

Brief Summary

Colonoscopy is a complex, highly operator dependent, practical skill. The consistent attainment of key performance indicators (KPIs) by endoscopists depends primarily upon training. Local factors can make training unstructured and contingent upon the observed practice of a small number of trainers. The investigators sought to demonstrate the feasibility and impact of a virtual-live one day colonoscopy-training course.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

July 10, 2023

Last Update Submit

October 25, 2023

Conditions

TrainingColonoscopyColorectal Cancer

Outcome Measures

Primary Outcomes (4)

  • Caecum Intubation rate

    Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: caecum intubation (intubated YES or No) after the training intervention

    3 months

  • Colonoscopy withdrawal time

    Trend in measurable colonoscopy key performance indicators pre- and post intervention. What is the withdrawal time (in minutes)? Is there a favourable trend in key performance indicator: colonoscopy withdrawal time (in minutes) after the training intervention

    3 months

  • Patient comfort during colonoscopy - Visual analogue scale

    Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: patient comfort (Visual analogue scale-number between 0-10, with 0=no pain and 10=worse pain possible) after the training intervention

    3 months

  • Patient comfort during colonoscopy - Sedation

    Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: patient comfort (amount of sedation necessary/used: midazolam (mg) and/or fentanyl (micrograms)) after the training intervention

    3 months

Study Arms (1)

Interventional arm

OTHER

All participant trainees will undergo the educational intervention, therefore there is only one arm since all participants will undergo the intervention. The intervention is a day where participants (the trainees) will undergo a full day of training in colonoscopy. Comparison of key performance measures in colonoscopy is made before and after the intervention.

Other: Training intervention

Interventions

Training interventionOTHER

Trainees underwent a one-day training course (intervention) by consciously competent endoscopists who were physically remote consisting of interactive theoretical sessions and live sessions, where trainees performed colonoscopy in their local endoscopy unit receiving real-time instructions via a tele-conference monitor. Trainers and trainees not doing the colonoscopy, followed the procedure in real-time. KPIs were assessed on trainee-performed colonoscopies for 3 weeks prior and 4 weeks after the intervention.

Interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • trainees: trainees in endoscopy who work at the University Hospital of Ghent who want to participate and who consent for the study
  • patients: all patients presenting for a colonoscopy between October and December 2020 and who consent to participate

You may not qualify if:

  • trainees: trainees in endoscopy who work at the University Hospital of Ghent who do not want to participate and who don't consent for the study
  • patients: all patients presenting for a colonoscopy between October and December 2020 and who do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David J Tate, Dr.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

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

July 10, 2023

First Posted

October 26, 2023

Study Start

October 1, 2020

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)