NCT03329339

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonoscopy
• Colon Polyp
• Bowel Preparation Solutions

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-15
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-11-06
• Last updated: 2017-11-06