Bowel PreparationNCT02093156
A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
An observational study of Bowel Preparation and Ottawa Score, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Ottawa Score
- What is being tested?
- Bowel preparation instructions
- How many people
- 605 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2013to Dec 2013
- How long will I take part?
- 1 Week
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective study involving two tertiary centers in China. The patients of the training cohort were enrolled from the Endoscopy Center of Xijing Hospital of Digestive Diseases in China. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital in China.
Who may be able to join
- Patients aged 18-90 years old who undergoing colonoscopy
Who cannot join
- failed colonoscopy because of technical chanllenge or poor tolerance of patients
- history of colorectal surgery
- prior finding of severe colonic stricture or obstructing tumor
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction or ileum
Show all 9Show fewer
- known or suspected bowel obstruction or perforation
- pregnancy
- unable to give informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710032
About this study
Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which can be broadly categorized as patient-related or procedure-related. It has been shown that split-dose regimen or some modified educational strategies can improve the quality of bowel preparation. For the patients with possible IBP before the performing of colonoscopy, it may be better to repeat bowel preparation with modified or enhanced strategies in case of failed intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a model to predict the quality of bowel preparation individually.
- Conditions
- Bowel Preparation, Ottawa Score
- Being tested
- Bowel preparation instructions
- Keywords
- bowel preparation, Ottawa Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel preparation instructionsOther
The same-day preparation method was used as previously reported. Briefly, all patients were instructed to have a regular diet for breakfast and lunch, but only clear liquids for dinner on the day before the colonoscopy. They were asked to drink two bags of PEG-ELP (polyethylene glycol electrolyte powder) dissolved in 2 L of water, or 45 mL of sodium phosphate be diluted in 240 mL of cool water follow with at least 1.5 L of water at 05:00-06:00 h within 2 h on the day of colonoscopy. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| training cohort | the training cohort was used to establish the bowel preparation score (BPS) Receives: Other: Bowel preparation instructions | |
| validation cohort | the validation cohort was used to verify the BPS (bowel preparation score) Receives: Other: Bowel preparation instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2
The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons.
Measured: up to 4 months
Secondary outcomes (1)
Polyp detection rate
The proportion of participants with at least one polyp in each group
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093156
- Sponsor's protocol ID
- 20130910-3
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT02093156
- Acronym / sponsor ID
- 20130910-3
- Conditions
- Bowel Preparation, Ottawa Score
- Keywords
- bowel preparation, Ottawa Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2014 (estimated)
- 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 is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which can be broadly categorized as patient-related or procedure-related. It has been shown that split-dose regimen or some modified educational strategies can improve the quality of bowel preparation. For the patients with possible IBP before the performing of colonoscopy, it may be better to repeat bowel preparation with modified or enhanced strategies in case of failed intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a model to predict the quality of bowel preparation individually.
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | Other: Bowel preparation instructionsthe training cohort was used to establish the bowel preparation score (BPS) |
| validation cohort | – | Other: Bowel preparation instructionsthe validation cohort was used to verify the BPS (bowel preparation score) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective study involving two tertiary centers in China. The patients of the training cohort were enrolled from the Endoscopy Center of Xijing Hospital of Digestive Diseases in China. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital in China.
Key inclusion criteria (1 listed)
- Patients aged 18-90 years old who undergoing colonoscopy
Key exclusion criteria (9 listed)
- failed colonoscopy because of technical chanllenge or poor tolerance of patients
- history of colorectal surgery
- prior finding of severe colonic stricture or obstructing tumor
- dysphagia
- compromised 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 |
|---|---|---|
| Bowel preparation instructionsThe same-day preparation method was used as previously reported. Briefly, all patients were instructed to have a regular diet for breakfast and lunch, but only clear liquids for dinner on the day before the colonoscopy. They were asked to drink two bags of PEG-ELP (polyethylene glycol electrolyte powder) dissolved in 2 L of water, or 45 mL of sodium phosphate be diluted in 240 mL of cool water follow with at least 1.5 L of water at 05:00-06:00 h within 2 h on the day of colonoscopy. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy. | Other | training cohort, validation cohort |
Primary outcome
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Time frame: up to 4 months
Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2 The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons.
1 secondary outcome
Polyp detection rate
Time frame: up to 4 months
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 20 Mar 2014.
- Colonoscopy completion in a large safety net health care systemLink provided by the sponsor.
- Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trialsLink provided by the sponsor.
- Development and validation of a novel patient educational booklet to enhance colonoscopy preparationLink provided by the sponsor.
- Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled studyLink provided by the sponsor.
- Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopyLink provided by the sponsor.
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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. 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 Bowel Preparation and Ottawa Score, run by Air Force Military Medical University, China at 2 sites 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 1 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: finished, as of the sponsor's last update on 20 Mar 2014. 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 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?
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?
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6 (time frame: up to 4 months). 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 20 Mar 2014.