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

Inje University

Status and phase: Completed; Phase 3

Conditions: Colonoscopy; Bowel Preparation

Treatments: Drug: high volume PEG; Drug: Low volume PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT01568814

1.0-A2012

Details and patient eligibility

About

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.

Full 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

Enrollment: 188 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups, including a placebo group

High volume PEG

Placebo Comparator group

Description:

Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.

Treatment:

Drug: high volume PEG

Low volume PEG with low residual meals

Active Comparator group

Description:

Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.

Treatment:

Drug: Low volume PEG