Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

Study Overview
=================
Brief Summary
-----------------
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Detailed Description
-----------------
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Official Title
-----------------
Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study

Conditions
-----------------
Bowel Cleansing Quality, Colonoscopy

Intervention / Treatment
-----------------
* Drug: Polyethylene Glycol (PEG)
* Drug: Polyethylene Glycol (PEG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 or older patients undergoing colonoscopy Exclusion Criteria: patients with a history of colorectal surgery patients with severe colonic stricture or obstructing tumor patients with dysphagia patients with compromised swallowing reflex or mental status patients with significant gastroparesis or gastric outlet obstruction patients with known or suspected bowel obstruction or perforation patients with severe chronic renal failure (creatinine clearance<30 ml/min) patients with severe chronic renal failure (creatinine clearance<30 ml/min) patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg) patients with inflammatory bowel disease or megacolon patients with dehydration patients with dehydration patients with pregnancy or lactation patients hemodynamically unstable patients unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: standard group<br>Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. | Drug: Polyethylene Glycol (PEG)<br>* participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.<br>|
| Experimental: Group B: tailored group<br>Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage). Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen. | Drug: Polyethylene Glycol (PEG)<br>* High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen.<br>* Other names: High-dose Bowel Preparation Regimen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate bowel preparation rates between 2 groups. | adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS) | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel preparation, colonoscopy, predictive model