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

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Seoul National University

Status

Completed

Conditions

Bowel Preparation Solutions
Colon Polyp
Colonoscopy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03329339
B-1505-297-003

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

2 L PEG with ascorbic acid group
No Intervention group
1 L PEG with ascorbic acid with PLD
Experimental group
Treatment:
Procedure: 1 L PEG with ascorbic acid with prepackaged, low residue diet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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