The Comparative Study Between Bowel Preparation Method

Phase 3

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Colonoscopy after bowel cleansing

• Registration Number: NCT01964417
• Lead Sponsor: Inje University

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4L-split Dose of PEG Solution	Colonoscopy after bowel cleansing	4L-split Dose of PEG Solution for bowel preparation
Low-volume PEG Plus Ascorbic Acid	Colonoscopy after bowel cleansing	Low-volume PEG Plus Ascorbic Acid for bowel preparation

Primary Outcome Measures

Name	Time	Method
Comparison of colon cleansing between the two solutions using Ottawa scale	3month

Trial Locations

Locations (1)

Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of