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RecruitingNCT07355777

Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation

Prospective Multicenter Randomized Trial Comparing Oral Explanation Alone and With Video Tutorial for Bowel Preparation Quality and Adenoma Detection

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
574 (estimated)
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed description

The quality of the colonic preparation is essential for the quality of the colonic examination: in one hand, a good preparation will allow the feasibility of the colonoscopy and will allow a complete examination. On the other hand, the presence of stercoral residues due to a bad colonic preparation reduces the sensitivity of the examination by hiding small lesions or with a very discreet relief. A poorer quality will also increase the length of the examination, which increase the risk of complications. However, in the literature, 20 to 30% of poor colonic preparation is found and 5% of colonoscopies are incomplete, including 42% due to poor preparation. The Pacôme survey, reveals that 6% of patients did not have prior consultation with the gastroenterologist. In addition, if 81% of patients were informed of the importance of the preparation, only 64% were aware of its practical modalities. Only 57% of patients were aware of the risks of inadequate preparation, despite the fact that doctors feel they have well informed their patients. It is also reported in "2 days of endoscopy 2008", that 8% of the information is given by someone other than the gastroenterologist himself. These data demonstrate that there is a heterogeneity in the explanatory content of the consultation prior to the colonoscopy examination. This can then explain the rate of poor quality colonic preparation and consequently the colonoscopy examination. The consultation must be a real therapeutic education and must be sufficiently informative to result in a colonic preparation of quality. We then hypothesize that an informative explanation in the form of a tutorial film would ensure homogeneous and standardized information between practitioners. In addition, the tutorial film will be available to be viewed at home several times by the patient, which may reduce the risk of misunderstanding.

Conditions

Interventions

TypeNameDescription
PROCEDUREColonoscopyThe 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.

Timeline

Start date
2025-04-01
Primary completion
2026-03-31
Completion
2026-03-31
First posted
2026-01-21
Last updated
2026-01-21

Locations

5 sites across 1 country: France

Source: ClinicalTrials.gov record NCT07355777. Inclusion in this directory is not an endorsement.