Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation (PREPACOTUTO)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status: Enrolling

Conditions: Gastro-Intestinal Disorder; Colonoscopy

Treatments: Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07355777

PREPACO -TUTO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 574 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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574 participants in 2 patient groups

face to face + Tutorial

Experimental group

Description:

one 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.

Treatment:

Procedure: Colonoscopy

face to face

Active Comparator group

Description:

The 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.

Treatment:

Procedure: Colonoscopy