Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

Not Applicable

• Conditions: Colonoscopy; Bowel Preparation
• Interventions: Drug: 2L Polyethylene Glycol (PEG); Drug: 4L Polyethylene Glycol (PEG)

• Registration Number: NCT03765216
• Lead Sponsor: Shandong University

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 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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05
• Study Start: 2019-01-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: tailored group	2L Polyethylene Glycol (PEG)	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.
Group B: tailored group	4L Polyethylene Glycol (PEG)	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.
Group A: standard group	2L Polyethylene Glycol (PEG)	Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate	2 months	Polyp detection rates between 2 groups

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Ji'nan, Shandong, China