A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

NCT ID: NCT02093156

Last Updated: 2014-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation Ottawa Score

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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training cohort

the training cohort was used to establish the bowel preparation score (BPS)

Bowel preparation instructions

Intervention Type OTHER

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)

Bowel preparation instructions

Intervention Type OTHER

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.

Interventions

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Bowel preparation instructions

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Shaanxi Second People's Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/18304886

Colonoscopy completion in a large safety net health care system

http://www.ncbi.nlm.nih.gov/pubmed/21628016

Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials

http://www.ncbi.nlm.nih.gov/pubmed/?term=21483463

Development and validation of a novel patient educational booklet to enhance colonoscopy preparation

http://www.ncbi.nlm.nih.gov/pubmed/23503044

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

http://www.ncbi.nlm.nih.gov/pubmed/22840295

Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy

Other Identifiers

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20130910-3

Identifier Type: -

Identifier Source: org_study_id

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