The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

Study Overview
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Brief Summary
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The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation. The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

Official Title
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The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study

Conditions
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Colonoscopy, Bowel Preparation, Predictive Model

Intervention / Treatment
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* Drug: Polyethylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 75 years Patients undergoing morning colonoscopy Exclusion Criteria: colon resection; suspected bowel obstruction; moderate or severe complications related to drinking the 1st or 2rd dose of PEG hemodynamically unstable; lactating or pregnant women; no need to reach the ileocecal segment unwilling to provided informed content.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Colonoscopy was performed in the control group directly. | |
| Experimental: model-based interference group<br>Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group colonoscopy directly. | Drug: Polyethylene glycol<br>* Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate bowel preparation | Defined by each segmental BBPS≥2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of participants with at least one adenoma in each group | 6 months | 
| Overall complication related to bowel preparation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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factors, bowel preparation, colonoscopy