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

NCT03329339 | Completed

• 1 other identifier: B-1505-297-003
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy; Colon Polyp; Bowel Preparation Solutions

Keywords

diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability and adverse events

  assessed at the colonoscopy day

Study Arms (2)

2 L PEG with ascorbic acid group

NO INTERVENTION

1 L PEG with ascorbic acid with PLD

EXPERIMENTAL

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

Interventions

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.

1 L PEG with ascorbic acid with PLD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Related Publications (1)

• 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.

  PMID: 30278110 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: November 6, 2017
• Study Start: May 15, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-10