Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation

Phase 3

Completed

• Conditions: Colonoscopy; Bowel Preparation
• Interventions: Drug: itopride

• Registration Number: NCT01513096
• Lead Sponsor: Inje University

Brief Summary

In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Detailed Description

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Patient who are scheduled for colonoscopy

Exclusion Criteria

• pregnancy,
• breast feeding,
• known or suspected bowel obstruction, and
• known allergy to PEG or Itopride ,
• presence of severe illness(renal failure, congestive heart failure, liver failure,), and
• refusal of consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split dose PEG with prokinetics	itopride	Bowel preparation using split-dose PEG with prokinetics

Primary Outcome Measures

Name	Time	Method
bowel cleaning quality according to Ottawa scale scores	3 months

Secondary Outcome Measures

Name	Time	Method
procedure time and polyp detection rate	3 months	cecal intubation time, polyp detection rate, degree of patient discomfort

Trial Locations

Locations (1)

Haeundae Paik Hospital, Inje University School of Medicine; 🇰🇷 Busan, Korea, Republic of