Clinical trial NCT03270046: The Effects of An Addition of Water Enema to PEG for Colon Preparation
Official title: The Effects of An Addition of Water Enema to PEG for Colon Preparation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma, Bile Duct
Keywords: Bowel preparation
CRC screening
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants will be randomised 1:1 to water enema group or no water enema group using blocked randomization with random block sizes.
Primary purpose: DIAGNOSTIC

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bowel preparation quality using Ottawa Bowel Preparation Scale
timeFrame: 1 days
Secondary outcomes:
measure: The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate
timeFrame: 1 days
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination
timeFrame: 1 day
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times
timeFrame: 1 day
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Somchai Leelakusolvong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: