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Clinical Trials/NCT01964417
NCT01964417
Completed
Phase 3

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

Inje University1 site in 1 country319 target enrollmentSeptember 2013

Overview

Phase
Phase 3
Intervention
Colonoscopy after bowel cleansing
Conditions
Colonoscopy
Sponsor
Inje University
Enrollment
319
Locations
1
Primary Endpoint
Comparison of colon cleansing between the two solutions using Ottawa scale
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jongha Park

Inje University

Inje University

Eligibility Criteria

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.)

Arms & Interventions

4L-split Dose of PEG Solution

4L-split Dose of PEG Solution for bowel preparation

Intervention: Colonoscopy after bowel cleansing

Low-volume PEG Plus Ascorbic Acid

Low-volume PEG Plus Ascorbic Acid for bowel preparation

Intervention: Colonoscopy after bowel cleansing

Outcomes

Primary Outcomes

Comparison of colon cleansing between the two solutions using Ottawa scale

Time Frame: 3month

Study Sites (1)

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