- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093156
A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
March 19, 2014 updated by: Yanglin Pan, Air Force Military Medical University, China
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
605
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Endoscopic center, Xijing Hospital of Digestive Diseases
-
Xi'an, Shaanxi, China, 710032
- Shaanxi Second People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Patients aged 18-90 years old who undergoing colonoscopy
Exclusion Criteria:
- 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
- known or suspected bowel obstruction or perforation
- pregnancy
- unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
training cohort
the training cohort was used to establish the bowel preparation score (BPS)
|
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.
|
validation cohort
the validation cohort was used to verify the BPS (bowel preparation score)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polyp detection rate
Time Frame: up to 4 months
|
The proportion of participants with at least one polyp in each group
|
up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- Colonoscopy completion in a large safety net health care system
- Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials
- Development and validation of a novel patient educational booklet to enhance colonoscopy preparation
- 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 study
- Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
March 19, 2014
First Submitted That Met QC Criteria
March 19, 2014
First Posted (ESTIMATE)
March 20, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 20, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20130910-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Preparation
-
University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
-
Alexandra Hospital, Athens, GreeceRecruitingBowel Preparation | Preparation for ColonoscopyGreece
-
Inje UniversityUnknownBOWEL PREPARATION (BOWEL CLEANSING)Korea, Republic of
-
Jinling Hospital, ChinaRecruiting
-
Ferring PharmaceuticalsRecruitingBowel PreparationUnited States
-
Taejoon Pharmaceutical Co., Ltd.Completed
-
Azienda USL ModenaCompleted
-
Shandong UniversityUnknownBowel PreparationChina
-
Samsung Medical CenterCompletedBowel PreparationKorea, Republic of
Clinical Trials on Bowel preparation instructions
-
Harminder SinghCompletedColonoscopy | Patient ComplianceCanada
-
Braintree LaboratoriesCompletedBowel Preparation for ColonoscopyUnited States
-
Nantes University HospitalRecruiting
-
Hamilton Health Sciences CorporationMcMaster UniversityUnknownAnastomotic Leak | Surgical Site InfectionCanada
-
Ningbo No. 1 HospitalCompletedBowel Preparation | Post-polypectomy Bleeding | Urgent ColonoscopyChina
-
Casen Recordati S.L.CompletedBowel Preparation for ColonoscopySpain
-
Changhai HospitalUnknownAdenoma Detection Rate | Bowel Preparation ScaleChina
-
Sunil PatelCompletedColonoscopy | Mass Screening | Colorectal Cancer ScreeningCanada
-
Assistance Publique - Hôpitaux de ParisCompletedPatients With Rectal CancerFrance
-
Beijing Friendship HospitalRecruitingAcute Lower Gastrointestinal BleedingChina