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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Bowel Preparation Solutions Colon Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

1 L PEG with ascorbic acid with prepackaged, low residue diet

Procedure

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 outcomes

Achievement of preparation adequacy

Time frame: assessed at the colonoscopy day

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 outcomes

Tolerability and adverse events

Time frame: assessed at the colonoscopy day

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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 6, 2017
Registry last updated: Nov 6, 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.

Published trials that share one or more normalized conditions with this study.

Completed