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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Gastro-Intestinal Disorder
• Intervention / Treatment: Procedure: Colonoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 574
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc O'BRIEN; Phone Number: 00334.78.61.81.28; Email: MOBRIEN@SAINTJOSEPHSAINTLUC.FR
• Study Contact Backup: Name: Sophie ARMAND; Phone Number: 0033478618091; Email: SARMAND@SAINTJOSEPHSAINTLUC.FR

Study Locations

• France
  • Lyon, France, 69007
    • Recruiting
    • Saint Joseph Saint Luc Hospital, Lyon, RHONE-ALPES
    • Contact: Marc O'BRIEN; Phone Number: 0033 4.78.61.81.28; Email: mobrien@saintjosephsaintluc.fr
    • Contact: Sophie ARMAND; Phone Number: 0033 4.78.61.80.91; Email: sarmand@saintjosephsaintluc.fr
    • Principal Investigator: Marc O'BRIEN
  • Lyon, France
    • Recruiting
    • Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire
    • Contact: David TAVAN
  • Lyon, France
    • Recruiting
    • Clinique du Val d'ouest 39 chemin de la Vernique 69130 Ecully
    • Contact: Anne-Marie MARION-AUDIBERT; Phone Number: 00334 72 19 31 81; Email: doc.amma@wanadoo.fr
  • Lyon, France
    • Recruiting
    • Clinique Médico-Chirurgicale Charcot 51 rue Commandant Charcot 69110 Sainte-Foy-lès-lyon
    • Contact: Maxime DELVINCOURT
  • Lyon, France
    • Recruiting
    • Les portes du sud 2 avenue du 11 novembre 1918 69200 Vénissieux
    • Contact: Gildas PHELIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: face to face + Tutorial; 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.	Procedure: Colonoscopy; 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.
Active Comparator: face to face; 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.	Procedure: Colonoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the colonoscopy procedure
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.	During the colonoscopy procedure
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.	From the colonoscopy procedure to one day after

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Collaborators: Clinique Charcot; Infirmerie Protestante de Lyon; Clinique du Val d'ouest
• Investigators: Principal Investigator: Marc O'BRIEN, Hôpital Saint Joseph Saint Luc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: colonoscopy; colon preparation; gastro-intestinal disorder; tutorial
• Additional Relevant MeSH Terms: Digestive System Diseases; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: PREPACO -TUTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No