NCT03329339

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

Completed NA Last updated 6 November 2017

What this trial tests

NA trial testing 1 L PEG with ascorbic acid with prepackaged, low residue diet in Colonoscopy in 200 participants. Completed in 31 December 2016.

Timeline

15 May 2015

Primary endpoint
31 December 2016

31 December 2016

Quick facts

Lead sponsor	Seoul National University Bundang Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	15 May 2015
Primary completion	31 December 2016
Estimated completion	31 December 2016

Drugs / interventions tested

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

Conditions studied

• Colonoscopy — all drugs for Colonoscopy →
• Colon Polyp — all drugs for Colon Polyp →
• Bowel Preparation Solutions — all drugs for Bowel Preparation Solutions →

Sponsor

Seoul National University Bundang Hospital

Who can join

Adults 18 to 85, any sex, with Colonoscopy or Colon Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Favorable outcomes of prepackaged low-residue diet on bowel preparation for colonoscopy: Endoscopist-blinded randomized controlled trial.
   Lee JW, Choi JY, Yoon H, Shin CM, et al · · 2019 · cited 8× · PMID 30278110 · DOI 10.1111/jgh.14499