Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Saint Joseph Saint Luc de Lyon
About this trial
Colonoscopy which is the standard examination for the exploration of the colon and rectum is performed very frequently.
Colon preparation before the examination is an essential step and pescription of the colonic preparation is carried out by the gastroenterologist.
However, despite a standardized explanation of the colon preparation, there is heterogeneity in understanding the colonic preparation, which in some cases compromises the quality of the colonoscopy examination. This clinical study aims to investigate whether an explanation of colonic preparation by tutorial films would increase the quality of colon preparation and would reach the recommendations of the Société française d'endoscopie digestive (SFED) in 2019.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consecutive patients undergoing their first colonoscopy for gastrointestinal symptoms, family history of CRC or suspected CRC.
Ability to use the internet and a link to a video.
Life expectancy over three months.
Patient ≥ 18 years old, requiring a colonoscopy procedure.
Disqualifiers
Patient with any psychiatric or psychological disorder that does not allow them a properd understanding and follow-up of the study.
Patient without internet access.
Patient requiring a colonoscopy procedure in emergency
Trial design
Design model
Parallel
Treatments tested in this trial
Colonoscopy
Procedure/SurgeryThe explanation of the colonic preparation will be done at home by film tutorial, before the colonic procedure or as usual, by the physician during a specific consultation before the colonic procedure but the quality of preparation will be evaluated by the boston score as usual.
Treatment groups
574 Participants
are divided into 2 treatment groupsGroup A: face to face + TutorialExperimental treatment 1 intervention
Group B: face to faceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of the quality of the colonic preparation by the boston score for each groupe
To date, the evaluation of the quality of the colonic preparation recognized by the SFED is the establishment of the Boston score. For each group, calculate the percentage of patients obtaining a Boston score ≥ 7. A Boston score ≥ 7 for a high-quality preparation is the score to be obtained according to the 2019 SFED recommendations for at least 90% of patients, excluding colonoscopies performed for emergencies.
Time frame
During the colonoscopy procedureSecondary outcomes
1
Detection rate of adenomas in each arm will be compared
Number of patients with the detection rate of adenomas in each group will be compared in order to determine if there is a difference of sensibility between the two types of colonic explanation
Time frame
During the colonoscopy procedure2
The rate of complete colonoscopy in each group
Number of patients with complete colonoscopy in each group will be compared in order to determine if there is a difference of faisability between the two types of colonic explanation.
Time frame
During the colonoscopy procedure3
Incidence of procedure- adverse events as assessed by complications reports
Number of patients with procedure-related adverse events will be reported to the pharmacovigilance department.
Time frame
From the colonoscopy procedure to one day afterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead sponsor
Clinique Charcot
Collaborator
Clinique du Val d'ouest
Collaborator
Infirmerie Protestante de Lyon
Collaborator
Source ClinicalTrials.gov