Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: 2L Polyethylene Glycol (PEG); Drug: 4L Polyethylene Glycol (PEG)

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Ji'nan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: standard group; Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.	Drug: 2L Polyethylene Glycol (PEG); Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; Other Names: Standard
Experimental: Group B: tailored group; 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: 2L Polyethylene Glycol (PEG); Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; Other Names: Standard; Drug: 4L Polyethylene Glycol (PEG); High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen; Other Names: High dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel preparation rates	Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	Polyp detection rates between 2 groups	2 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): March 15, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018SDU-QILU-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The individual participant data of this trial will be shared when necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No