Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation
PREPACOTUTO
Prospective Multicenter Randomized Trial Comparing Oral Explanation Alone and With Video Tutorial for Bowel Preparation Quality and Adenoma Detection
1 other identifier
interventional
574
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJanuary 21, 2026
January 1, 2026
12 months
September 29, 2025
January 13, 2026
Conditions
Keywords
Outcome Measures
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.
During the colonoscopy procedure
Secondary Outcomes (3)
Detection rate of adenomas in each arm will be compared
During the colonoscopy procedure
The rate of complete colonoscopy in each group
During the colonoscopy procedure
Incidence of procedure- adverse events as assessed by complications reports
From the colonoscopy procedure to one day after
Study Arms (2)
face to face + Tutorial
EXPERIMENTALone arm F+T "face to face + Tutorial" will have, in addition to all the items received by Group F, an email containing a link to a video tutorial explaining how to perform colonic preparation.
face to face
ACTIVE COMPARATORThe other arm F : "face to face" of patients will have the explanation of the colonic preparation and the administrative and legal documents of the centre's current practice by the gastro-enterologist.
Interventions
The 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Saint Joseph Saint Luc de Lyonlead
- Clinique Charcotcollaborator
- Clinique du Val d'ouestcollaborator
- Infirmerie Protestante de Lyoncollaborator
Study Sites (5)
Saint Joseph Saint Luc Hospital, Lyon, RHONE-ALPES
Lyon, 69007, France
Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire
Lyon, France
Clinique du Val d'ouest 39 chemin de la Vernique 69130 Ecully
Lyon, France
Clinique Médico-Chirurgicale Charcot 51 rue Commandant Charcot 69110 Sainte-Foy-lès-lyon
Lyon, France
Les portes du sud 2 avenue du 11 novembre 1918 69200 Vénissieux
Lyon, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc O'BRIEN
Hopital Saint Joseph Saint Luc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2025
First Posted
January 21, 2026
Study Start
April 1, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01