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NCT Number: NCT07355777

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

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.

Primary outcomes

  1. Assessment of the quality of the colonic preparation by the boston score for each groupe

    Time frame: During the colonoscopy procedure

    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.

Secondary outcomes

  1. Detection rate of adenomas in each arm will be compared

    Time frame: During the colonoscopy procedure

    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

  2. The rate of complete colonoscopy in each group

    Time frame: During the colonoscopy procedure

    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.

  3. Incidence of procedure- adverse events as assessed by complications reports

    Time frame: From the colonoscopy procedure to one day after

    Number of patients with procedure-related adverse events will be reported to the pharmacovigilance department.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc O'BRIEN

CONTACT

[email protected]

00334.78.61.81.28

Sophie ARMAND

CONTACT

[email protected]

0033478618091

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Collaborators

  • Clinique Charcot
  • Clinique du Val d'ouest
  • Infirmerie Protestante de Lyon

Registry information

Official study title

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

Acronym: PREPACOTUTO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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