Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

Shandong University600 enrolled

Overview

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.

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 improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

600

Conditions

Bowel Preparation Colonoscopy

Interventions

2L Polyethylene Glycol (PEG)DRUG

Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen

4L Polyethylene Glycol (PEG)DRUG

High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, China

Outcomes

Primary Outcomes

Adequate bowel preparation rates

Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)

Time frame: 2 months

Secondary Outcomes

Polyp detection rate

Polyp detection rates between 2 groups

Time frame: 2 months

Central Contacts

Li Yanqing, PhD,MD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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