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

Adenoma, Bile Duct Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270046
• Other study ID #: Si307/2014
• Status: Completed
• Phase: N/A
• First received: May 3, 2017
• Last updated: September 4, 2017
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Bile Duct

Intervention

Procedure:
• Water enema
Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel preparation quality using Ottawa Bowel Preparation Scale	Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record	1 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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