The Comparative Study Between Bowel Preparation Method (CSBPM)

January 9, 2014 updated by: Jongha Park, Inje University

The Comparative Study Between Bowel Preparation Method: 4L-split Dose of PEG Solution, Low-volume PEG Plus Ascorbic Acid Focusing on the Bowel Cleansing Efficacy, Patients' Affinity to Preparation Solution and Mucosal Injury

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

319

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of colon cleansing between the two solutions using Ottawa scale
Time Frame: 3month
3month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Jongha Park, MD, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEG-0488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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