A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Completed

• Conditions: Bowel Preparation; Ottawa Score
• Interventions: Other: Bowel preparation instructions

• Registration Number: NCT02093156
• Lead Sponsor: Air Force Military Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
training cohort	Bowel preparation instructions	the training cohort was used to establish the bowel preparation score (BPS)
validation cohort	Bowel preparation instructions	the validation cohort was used to verify the BPS (bowel preparation score)

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6	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.

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate	up to 4 months	The proportion of participants with at least one polyp in each group

Trial Locations

Locations (2)

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China

Shaanxi Second People's Hospital; 🇨🇳 Xi'an, Shaanxi, China