Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation

Phase 3

Completed

• Conditions: Bowel Preparation; Colonoscopy
• Interventions: Drug: high volume PEG; Drug: Low volume PEG

• Registration Number: NCT01568814
• Lead Sponsor: Inje University

Brief Summary

Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

Detailed Description

We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-29
• Last Update Submitted: 2012-03-30
• Study First Posted: 2012-04-02
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria

• Age under 18 years
• Pregnancy
• Breast feeding
• Prior history of surgical large bowel resection
• Severe medical condition such as severe cardiac
• Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
• Drug addiction or major psychiatric illness
• Suspected bowel obstruction or ileus
• Allergy to PEG
• Refusal of consent to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume PEG	high volume PEG	Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.
Low volume PEG with low residual meals	Low volume PEG	Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation	2 months	Quality of bowel preparation is assessed using Ottawa bowel preparation scale.

Secondary Outcome Measures

Name	Time	Method
Tolerability	2 months	Tolerability of bowel preparation regimen is assessed by patient questionnaire.

Trial Locations

Locations (1)

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