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

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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation Solutions; Colonoscopy; Colon Polyp
• Intervention / Treatment: Procedure: 1 L PEG with ascorbic acid with prepackaged, low residue diet

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2 L PEG with ascorbic acid group
Experimental: 1 L PEG with ascorbic acid with PLD	Procedure: 1 L PEG with ascorbic acid with prepackaged, low residue diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed at the colonoscopy day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	assessed at the colonoscopy day

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: diet
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: B-1505-297-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No