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

Primary Purpose

Adenoma, Bile Duct

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Water enema
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma, Bile Duct focused on measuring Bowel preparation, CRC screening

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    No enema group

    Water enema group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Bowel preparation quality using Ottawa Bowel Preparation Scale
    Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    May 3, 2017
    Last Updated
    September 4, 2017
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03270046
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoma, Bile Duct
    Keywords
    Bowel preparation, CRC screening

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No enema group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Water enema group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Water enema
    Intervention Description
    Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
    Primary Outcome Measure Information:
    Title
    Bowel preparation quality using Ottawa Bowel Preparation Scale
    Description
    Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record
    Time Frame
    1 days
    Secondary Outcome Measure Information:
    Title
    The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate
    Description
    Evaluate the adenoma detection rate compare between two groups
    Time Frame
    1 days
    Title
    The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination
    Description
    Evaluate the completeness of examination compare between two groups
    Time Frame
    1 day
    Title
    The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times
    Description
    Evaluate total and withdrawal times of colonoscopy procedures compare between two groups
    Time Frame
    1 day
    Title
    The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events
    Description
    Evaluate the safety and efficacy of procedures compare between two groups
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Somchai Leelakusolvong, M.D.
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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