A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Bowel Preparation Clinical Trial

Official title:

A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093156
• Other study ID #: 20130910-3
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 19, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Preparation
• Ottawa Score

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Shaanxi Second People's Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 4 months	No
Secondary	Polyp detection rate	The proportion of participants with at least one polyp in each group	up to 4 months	No

External Links

•   Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials
•   Colonoscopy completion in a large safety net health care system
•   Development and validation of a novel patient educational booklet to enhance colonoscopy preparation
•   Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy
•   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