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CompletedNCT01964417CSBPMUpdated Jan 13, 2014

The Comparative Study Between Bowel Preparation Method

A Phase 3 interventional study of Colonoscopy after bowel cleansing in Colonoscopy, sponsored by Inje University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-13.

Sponsored by Inje University · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
319
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.

Read the detailed description

This was a prospective randomized single-blinded clinical trial of ambulatory patients to assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.

Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by using the Ottawa bowel preparation assessment tool and preparation-induced mucosal inflammation. Acceptability was assessed by questionnaire.

02

Conditions studied

  • Colonoscopy

Keywords

  • BOWEL PREPARATION
  • PEG
  • Low-volume PEG Plus Ascorbic Acid
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In context

Lead sponsor

Inje University is the lead sponsor of 90 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients who want colonoscopy purposing screening among adults between the age of 20\~65

Exclusion criteria

Exclusion Criteria:

  • Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)
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Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
319 participants (actual)

Study arms

  • Active comparator
    4L-split Dose of PEG Solution

    4L-split Dose of PEG Solution for bowel preparation

    Drug: Colonoscopy after bowel cleansing

  • Active comparator
    Low-volume PEG Plus Ascorbic Acid

    Low-volume PEG Plus Ascorbic Acid for bowel preparation

    Drug: Colonoscopy after bowel cleansing

Interventions

  • DrugColonoscopy after bowel cleansing
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What researchers measure

Primary outcomes

  1. Comparison of colon cleansing between the two solutions using Ottawa scale

    Time frame: 3month

07

Study locations

1 site
  • Haeundae Paik Hospital
    Busan, 612-896, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01964417
Lead sponsor
Inje University
Responsible party
Jongha Park (Inje University, Inje University) — Principal investigator
First posted
Oct 17, 2013
Start date
Sep 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Jan 13, 2014

Study contacts

Jongha Park, MD
principal investigator · Inje University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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