Validation of a Prediction Model for Inadequate Bowel Preparation

General Hospital of Shenyang Military Region2,360 enrolled

Overview

We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this multicenter observational study is to validate the accuracy of this model.

The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.

Study Type

OBSERVATIONAL

Enrollment

2,360

Conditions

Bowel Preparation Colonoscopy

Interventions

Bowel preparation before colonoscopyPROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 94 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. adult patients (age is ≥18 years old); 2. patients undergoing colonoscopy; 3. written informed consent. Exclusion Criteria: 1. patients undergoing emergent colonoscopy; 2. patients with major psychiatric disorders; 3. pregnant or breast feeding patients; 4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency); 5. patients suspected to have intestinal obstruction, stenosis or perforation; 6. poor compliance with the bowel preparation protocol (poor compliance is indicated if the dose of medication was \< 75% of the prescribed dose; 7. incomplete colonoscopy because of other circumstances apart from inadequate cleansing 8. patients previously enrolled in this study.

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Quality of bowel preparation

A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation. Each segment of the colon is scored from 0 to 3, with higher scores indicating superior cleansing, and summed for a total score that can range from 0 to 9.

Time frame: During the procedure of colonoscopy

Secondary Outcomes

Adenoma and/or polyp detection rate

Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy

Time frame: During the procedure of colonoscopy

Number of polyps and/or adenomas

Number of polyps and/or adenomas detected during colonoscopy

Time frame: During the procedure of colonoscopy

Adverse events

Incidence of abdominal pain, bloating, nausea/vomiting after intake of purgative.

Time frame: Before the procedure of colonoscopy

Data from ClinicalTrials.gov

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