The Effects of An Addition of Water Enema to PEG for Colon Preparation

The Effects of An Addition of Water Enema to PEG for Colon Preparation: A Randomized Controlled Trial

The purpose of this study is to compare the preparation quality by using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening

Study Overview

• Status: Completed
• Conditions: Adenoma, Bile Duct
• Intervention / Treatment: Procedure: Water enema

Detailed Description

Background : Good bowel preparation improves the rate of polyp detection and the time of caecal intubation during colorectal cancer (CRC) screening.

Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG) solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel preparation and the delay between the last dose of bowel preparation and colonoscopy should be minimized and no longer than 4 hours.

The investigators hypothesize that the addition of water enema to the standard PEG bowel preparation could provide the better quality of bowel preparation and then result in improvement in the rate of adenoma detection among participants scheduled for CRC screening with preparation to procedure interval > 8 hr.

The purpose of this study is to compare the preparation quality using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening. The secondary aim is to compare the effect of the standard PEG bowel preparation and the addition of water enema in terms of adenoma detection rate, the completeness of the examination, total and withdrawal time, safety and adverse events among those scheduled for CRC screening.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for CRC screening
• Bowel preparation using 3 liters of PEG solution
• Colonoscopy performed at 8-16 hours after bowel preparation

Exclusion Criteria:

• History of a failed bowel preparation
• Previous colonic surgery
• Uncontrolled underlying disease
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: No enema group; Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy without water enema. Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication. The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale for evaluation of side effect, complication during PEG ingestion, enema and colonoscopy, and participant satisfactory.	Procedure: Water enema; Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
ACTIVE_COMPARATOR: Water enema group; Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy and enema with sterile water until stool was clear or patient felt discomfort but not exceed 3 liter, before colonoscopy. Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication.The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale.	Procedure: Water enema; Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation quality using Ottawa Bowel Preparation Scale	Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record	1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate	Evaluate the adenoma detection rate compare between two groups	1 days
The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination	Evaluate the completeness of examination compare between two groups	1 day
The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times	Evaluate total and withdrawal times of colonoscopy procedures compare between two groups	1 day
The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events	Evaluate the safety and efficacy of procedures compare between two groups	3 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Somchai Leelakusolvong, M.D., Mahidol University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: CRC screening; Bowel preparation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Adenoma, Bile Duct
• Other Study ID Numbers: Si307/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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