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Completed

NCT Number: NCT03270046

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water enema

Procedure

Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.

Primary outcomes

  1. Bowel preparation quality using Ottawa Bowel Preparation Scale

    Time frame: 1 days

    Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record

Secondary outcomes

  1. The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate

    Time frame: 1 days

    Evaluate the adenoma detection rate compare between two groups

  2. The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination

    Time frame: 1 day

    Evaluate the completeness of examination compare between two groups

  3. The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times

    Time frame: 1 day

    Evaluate total and withdrawal times of colonoscopy procedures compare between two groups

  4. The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events

    Time frame: 3 days

    Evaluate the safety and efficacy of procedures compare between two groups

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 1, 2017
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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