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

Colonoscopy Clinical Trial

— LOWPEG  

Official title:

Efficacy and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568814
• Other study ID #: 1.0-A2012
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: March 30, 2012
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: January 2012
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Drug:
• Low volume PEG
low volume polyethylene glycol 2 liter one time
• high volume PEG
high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital, Inje University School of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation	Quality of bowel preparation is assessed using Ottawa bowel preparation scale.	2 months	No
Secondary	Tolerability	Tolerability of bowel preparation regimen is assessed by patient questionnaire.	2 months	Yes