ColonoscopyNCT04475146
Impact of Visualisation an Explanatory Video on the Quality of Bowel Preparation
An observational study of Colonoscopy, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- video vizualisation
- How many people
- 282 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All major patients, without legal protection measures, understanding French and having access to the internet and an email address. Patient having a first outpatient colonoscopy with preparation by MOVIPREP. The study will be proposed by the investigator to patients followed for colonoscopy in the department of Hepato-gastroenterology. If patients accepted to participate in the protocol and the informed consent form is signed, patients will be included in the protocol.
Who may be able to join
- Major patient
- Patient with first indication of colonoscopy
- Colonoscopy performed in outpatient with preparation by MOVIPREP
- Patient affiliated with Social Security
- Informed consent signed by the patient
Who cannot join
- Hospitalized patients
- With no Internet access, or no access to the email
- Blind patients
- Patient who don't speak French
- Pregnant woman
- Severe constipation (3 stools/week) or long-term laxatives
- History of partial or total colectomy
- Other preparation product
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre hospitalier intercommunal de Créteil
Créteil, 94100
CHI Villeneuve St George
Villeneuve-Saint-Georges
About this study
Official title: Impact de la Visualisation d'Une vidéo Explicative Sur la qualité de la préparation Intestinale
The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation.
Read the detailed description
The prescription of colonoscopy is performed by a gastroenterologist, who chooses the type of bowel preparation. During this consultation, the doctor explains to the patient the bowel preparation, then gives the patient the prescription with the type of product and a sheet explaining the diet without residues.
The time between this consultation and the colonoscopy is sometimes long. The idea of this study is to accompany this information on intestinal preparation with a video that details the different stages of intestinal preparation by MOVIPREP. Indeed, studies have in the past shown an improvement in the quality of intestinal preparation with the help of better information to patients (educational booklet, or smartphone application)
- Conditions
- Colonoscopy
- Being tested
- video vizualisation
- Keywords
- video of bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video vizualisationOther
video vizualisation
| Study group | Role | What they receive |
|---|---|---|
| Standard information and video visualization | Standard information and video visualization Receives: Other: video vizualisation | |
| Standard information, no video | Standard information, no video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 "standard information and video visualization" versus in group 2 "standard information."
Boston score
Measured: Immediately after the colonoscopy
Secondary outcomes (1)
A scale of understanding and satisfaction in relation to the quality of Information on intestinal preparation.
Satisfaction and Understanding Questionnaires (Likert Scale)
Measured: 2 hours after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion1 Mar 2024
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475146
- Sponsor's protocol ID
- PREPAVIDEO
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de la Visualisation d'Une vidéo Explicative Sur la qualité de la préparation Intestinale
- ClinicalTrials.gov ID
- NCT04475146
- Acronym / sponsor ID
- PREPAVIDEO
- Conditions
- Colonoscopy
- Keywords
- video of bowel preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 17 Jul 2020 (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.
The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation.
Detailed description
The prescription of colonoscopy is performed by a gastroenterologist, who chooses the type of bowel preparation. During this consultation, the doctor explains to the patient the bowel preparation, then gives the patient the prescription with the type of product and a sheet explaining the diet without residues.
The time between this consultation and the colonoscopy is sometimes long. The idea of this study is to accompany this information on intestinal preparation with a video that details the different stages of intestinal preparation by MOVIPREP. Indeed, studies have in the past shown an improvement in the quality of intestinal preparation with the help of better information to patients (educational booklet, or smartphone application)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard information and video visualization | – | Other: video vizualisationStandard information and video visualization |
| Standard information, no video | – | –Standard information, no video |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patients, without legal protection measures, understanding French and having access to the internet and an email address. Patient having a first outpatient colonoscopy with preparation by MOVIPREP. The study will be proposed by the investigator to patients followed for colonoscopy in the department of Hepato-gastroenterology. If patients accepted to participate in the protocol and the informed consent form is signed, patients will be included in the protocol.
Key inclusion criteria (5 listed)
- Major patient
- Patient with first indication of colonoscopy
- Colonoscopy performed in outpatient with preparation by MOVIPREP
- Patient affiliated with Social Security
- Informed consent signed by the patient
Key exclusion criteria (8 listed)
- Hospitalized patients
- With no Internet access, or no access to the email
- Blind patients
- Patient who don't speak French
- Pregnant woman
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 |
|---|---|---|
| video vizualisationvideo vizualisation | Other | Standard information and video visualization |
Primary outcome
Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 "standard information and video visualization" versus in group 2 "standard information."
Time frame: Immediately after the colonoscopy
Boston score
1 secondary outcome
A scale of understanding and satisfaction in relation to the quality of Information on intestinal preparation.
Time frame: 2 hours after the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Centre Hospitalier Intercommunal Creteil at 2 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 "standard information and video visualization" versus in group 2 "standard information." (time frame: Immediately after the colonoscopy). 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 19 Sep 2024.