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

About this trial
This is an interventional treatment trial for Colonoscopy focused on measuring diet
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
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
NCT ID
NCT03329339
First Posted
October 9, 2017
Last Updated
October 27, 2017
Sponsor
Seoul National University Bundang Hospital
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
Learn more about this trial
The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation
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