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The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation

Primary Purpose

Colonoscopy, Colon Polyp, Bowel Preparation Solutions

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1 L PEG with ascorbic acid with prepackaged, low residue diet
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy focused on measuring diet

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • anyone who were scheduled for an outpatient colonoscopy below indication

    1. patient who need colonic polyp screening
    2. patient who have hematochezia
    3. patient who have fecal occult blood test positive result

Exclusion Criteria:

  • ileus
  • inflammatory bowel disease-
  • gastrointestinal malignancy
  • severe cardiac disease (heart failure beyond NYHA Class III)
  • chronic obstructive pulmonary disease,
  • decompensated liver cirrhosis; coagulopathy
  • Female patients with pregnant or breastfeeding.
  • who use long-term use of sedative, anti-spasmodic, prokinetic, laxative or anti-diarrheal medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    2 L PEG with ascorbic acid group

    1 L PEG with ascorbic acid with PLD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Achievement of preparation adequacy
    Definition: Achievement of preparation adequacy was defined by as having BBPS scores of 2 or 3 for all colon segments. BBPS was measured by Physician who performing colonoscopy. To maintain precise evaluation, the physician participated in an online training program from www.cori.org/bbps. For each colon segment, BBPS preparation score ranged 0 to 3. Definition of BBPS are presented at www.cori.org/bbps

    Secondary Outcome Measures

    Tolerability and adverse events
    Tolerability and adverse events were measured by comprehensive questionnaire. Participants were asked about the presence of distressing symptoms, such as abdominal pain/discomfort or nausea/vomiting, and if they had problems taking the entire dose. The subjects also reported the percentage of the preparation they completed (100%, 90~99%, <90%), regardless of solution or meals. Adverse events are categorized by CTCAE v4.03.

    Full Information

    First Posted
    October 9, 2017
    Last Updated
    October 27, 2017
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03329339
    Brief Title
    The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation
    Official Title
    1L Morning-only Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-residue Diet Versus 2L Polyethylene Glycol Plus Ascorbic Acid for Bowel Preparation: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 15, 2015 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    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
    Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large. Therefore, the present investigators evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA. Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue diet as bowel preparation for colonoscopy. Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding tolerability and safety were also gathered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonoscopy, Colon Polyp, Bowel Preparation Solutions
    Keywords
    diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 L PEG with ascorbic acid group
    Arm Type
    No Intervention
    Arm Title
    1 L PEG with ascorbic acid with PLD
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    1 L PEG with ascorbic acid with prepackaged, low residue diet
    Intervention Description
    Participants who were allocated to the 2 L PEG with ascorbic acid (PEGA) group took 250 ml of PEG with ascorbic acid at 15-min intervals, completing 1 L of the PEG with ascorbic acid protocol at 8:00 PM on the day prior to the procedure. The remaining 1 L of the PEG with ascorbic acid solution was administered in the same manner at 6:00 AM on the day of the procedure. Participants assigned to the 1 L PEG with ascorbic acid with PLD (PLD) group consumed a prepackaged, low residue diet (ZeroCol, Korea Medical Food Inc., Seoul, Korea) which consisted of a breakfast, lunch and dinner, the day prior to colonoscopy. The Participants took 1 L PEG with ascorbic acid solution at 6:00 AM on the day of the colonoscopy in the same way as described above. All of the subjects ingested 500 mL of water for every 1 L of 1 L PEG with ascorbic acid solution consumed. The Participants completed all of the administrations at least 2 hours before the colonoscopy.
    Primary Outcome Measure Information:
    Title
    Achievement of preparation adequacy
    Description
    Definition: Achievement of preparation adequacy was defined by as having BBPS scores of 2 or 3 for all colon segments. BBPS was measured by Physician who performing colonoscopy. To maintain precise evaluation, the physician participated in an online training program from www.cori.org/bbps. For each colon segment, BBPS preparation score ranged 0 to 3. Definition of BBPS are presented at www.cori.org/bbps
    Time Frame
    assessed at the colonoscopy day
    Secondary Outcome Measure Information:
    Title
    Tolerability and adverse events
    Description
    Tolerability and adverse events were measured by comprehensive questionnaire. Participants were asked about the presence of distressing symptoms, such as abdominal pain/discomfort or nausea/vomiting, and if they had problems taking the entire dose. The subjects also reported the percentage of the preparation they completed (100%, 90~99%, <90%), regardless of solution or meals. Adverse events are categorized by CTCAE v4.03.
    Time Frame
    assessed at the colonoscopy day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: anyone who were scheduled for an outpatient colonoscopy below indication patient who need colonic polyp screening patient who have hematochezia patient who have fecal occult blood test positive result Exclusion Criteria: ileus inflammatory bowel disease- gastrointestinal malignancy severe cardiac disease (heart failure beyond NYHA Class III) chronic obstructive pulmonary disease, decompensated liver cirrhosis; coagulopathy Female patients with pregnant or breastfeeding. who use long-term use of sedative, anti-spasmodic, prokinetic, laxative or anti-diarrheal medications

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30278110
    Citation
    Lee JW, Choi JY, Yoon H, Shin CM, Park YS, Kim N, Lee DH. Favorable outcomes of prepackaged low-residue diet on bowel preparation for colonoscopy: Endoscopist-blinded randomized controlled trial. J Gastroenterol Hepatol. 2019 May;34(5):864-869. doi: 10.1111/jgh.14499. Epub 2018 Oct 24.
    Results Reference
    derived

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    The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation

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