ColonoscopyPREPACOTUTONCT07355777
Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation
A study testing Colonoscopy in people with Colonoscopy and Gastro-Intestinal Disorder, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Gastro-Intestinal Disorder
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Saint Joseph Saint Luc Hospital, Lyon, RHONE-ALPES
Lyon, 69007
Marc O'BRIEN, 0033 4.78.61.81.28, mobrien@saintjosephsaintluc.fr
Sophie ARMAND, 0033 4.78.61.80.91, sarmand@saintjosephsaintluc.fr
- Recruiting
Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire
Lyon
David TAVAN
- Recruiting
Clinique du Val d'ouest 39 chemin de la Vernique 69130 Ecully
Lyon
Anne-Marie MARION-AUDIBERT, 00334 72 19 31 81, doc.amma@wanadoo.fr
- Recruiting
Clinique Médico-Chirurgicale Charcot 51 rue Commandant Charcot 69110 Sainte-Foy-lès-lyon
Lyon
Maxime DELVINCOURT
- Recruiting
Les portes du sud 2 avenue du 11 novembre 1918 69200 Vénissieux
Lyon
Gildas PHELIP
About this study
Official title: 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.
Read the 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
- Colonoscopy, Gastro-Intestinal Disorder
- Being tested
- Colonoscopy
- Keywords
- colon preparation, colonoscopy, gastro-intestinal disorder, tutorial
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| face to face + Tutorial | Experimental | 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. Receives: Procedure: Colonoscopy |
| face to face | Active comparator | 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. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the colonoscopy procedure
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: From the colonoscopy procedure to one day after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Charcot, Clinique du Val d'ouest, Infirmerie Protestante de Lyon
- Responsible party
- Sponsor
- Investigators
- Marc O'BRIEN, Principal investigator, Hopital Saint Joseph Saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355777
- Sponsor's protocol ID
- PREPACO -TUTO
- Acronym
- PREPACOTUTO
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Trial Comparing Oral Explanation Alone and With Video Tutorial for Bowel Preparation Quality and Adenoma Detection
- ClinicalTrials.gov ID
- NCT07355777
- Acronym / sponsor ID
- PREPACOTUTO / PREPACO -TUTO
- Conditions
- Colonoscopy, Gastro-Intestinal Disorder
- Keywords
- colon preparation, colonoscopy, gastro-intestinal disorder, tutorial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 574 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Collaborators
- Clinique Charcot, Clinique du Val d'ouest, Infirmerie Protestante de Lyon
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face to face + Tutorial | Experimental | Procedure: Colonoscopyone 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 comparator | Procedure: ColonoscopyThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyThe 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. | Procedure or surgery | face to face, face to face + Tutorial |
Primary outcome
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.
3 secondary outcomes
Detection rate of adenomas in each arm will be compared
Time frame: During the colonoscopy procedure
The rate of complete colonoscopy in each group
Time frame: During the colonoscopy procedure
Incidence of procedure- adverse events as assessed by complications reports
Time frame: From the colonoscopy procedure to one day after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc O'BRIEN principal investigator
Hopital Saint Joseph Saint Luc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Colonoscopy and Gastro-Intestinal Disorder, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc O'BRIEN (00334.78.61.81.28, MOBRIEN@SAINTJOSEPHSAINTLUC.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the quality of the colonic preparation by the boston score for each groupe (time frame: During the colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.