Bowel Preparation ScaleNCT03185299
Impact of Reinforced Education by Video on the Quality of Bowel Preparation
A study testing Video and Standard preparation instructions in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai Hospital at 1 site in China.
Trial summary
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Scale, Adenoma Detection Rate
- What is being tested?
- Video and Standard preparation instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2017to 4 Aug 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- outpatients aged 18-80 years
- referred for routine diagnostic colonoscopy
- with access to the educational video themselves or through close family members living in the same household were eligible.
Who cannot join
- pregnancy or breastfeeding
- allergy to purgatives
- suspected intestinal obstruction, stricture, or perforation
- hemodynamic instability
- impaired swallowing reflex or mental status
- severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
Show all 9Show fewer
- illiteracy
- history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
- participation declined.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by video 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Being tested
- Video, Standard preparation instructions
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing
Standard preparation instructionsOther
The control arm will receive written instruction on preparing for a colonoscopy per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing Receives: Other: Video |
| Standard preparation instructions | Experimental | The control arm will receive written instruction on preparing for a colonoscopy per standard of care Receives: Other: Standard preparation instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale
The primary end point of the study was adequate bowel prepara- tion quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
Measured: 2 days
Secondary outcomes (2)
Polyp detection rate
Secondary end points included polyp detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
Measured: 2 days
Adenoma detection rate
Secondary end points included adenoma detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start4 Jul 2017 (estimated)
- Primary completion4 Jun 2018 (estimated)
- Study completion4 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation ScaleStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Yu, Prof, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185299
- Sponsor's protocol ID
- VIDEO
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rice SC, Higginbotham T, Dean MJ, Slaughter JC, Yachimski PS, Obstein KL. Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Nov;111(11):1564-1571. doi: 10.1038/ajg.2016.450. Epub 2016 Oct 18.
PubMed 27753434
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reinforced Education by Video on the Quality of Bowel Preparation
- ClinicalTrials.gov ID
- NCT03185299
- Acronym / sponsor ID
- VIDEO
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 4 Jul 2017 (estimated)
- Primary completion
- 4 Jun 2018 (estimated)
- Study completion
- 4 Aug 2018 (estimated)
- First posted
- 14 Jun 2017 (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.
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by video 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Other: VideoPatients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing |
| Standard preparation instructions | Experimental | Other: Standard preparation instructionsThe control arm will receive written instruction on preparing for a colonoscopy per standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- outpatients aged 18-80 years
- referred for routine diagnostic colonoscopy
- with access to the educational video themselves or through close family members living in the same household were eligible.
Key exclusion criteria (9 listed)
- pregnancy or breastfeeding
- allergy to purgatives
- suspected intestinal obstruction, stricture, or perforation
- hemodynamic instability
- impaired swallowing reflex or mental status
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 |
|---|---|---|
| VideoPatients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing | Other | Video |
| Standard preparation instructionsThe control arm will receive written instruction on preparing for a colonoscopy per standard of care | Other | Standard preparation instructions |
Primary outcome
Boston Bowel Preparation Scale
Time frame: 2 days
The primary end point of the study was adequate bowel prepara- tion quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
2 secondary outcomes
Polyp detection rate
Time frame: 2 days
Adenoma detection rate
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Results publication: PubMed 27753434Rice SC, Higginbotham T, Dean MJ, Slaughter JC, Yachimski PS, Obstein KL. Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Nov;111(11):1564-1571. doi: 10.1038/ajg.2016.450. Epub 2016 Oct 18.
- Individual participant dataSharing planned: Undecided
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Quality of Bowel Preparation
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.
Zhaoshen Yu, Prof study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Standard preparation instructions in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai Hospital at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, Prof (+86-21-31161335, zhaosli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185299, which also lists 1 linked publication.
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 14 Jun 2017.