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

Not Applicable

Completed

• Conditions: Bowel Preparation Solutions; Colonoscopy; Colon Polyp
• Interventions: Procedure: 1 L PEG with ascorbic acid with prepackaged, low residue diet

• Registration Number: NCT03329339
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-27
• Last Update Submitted: 2017-10-27
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 L PEG with ascorbic acid with PLD	1 L PEG with ascorbic acid with prepackaged, low residue diet	-

Primary Outcome Measures

Name	Time	Method
Achievement of preparation adequacy	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 Outcome Measures

Name	Time	Method
Tolerability and adverse events	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.