Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy (SP2HP)

Inje University

Status and phase: Unknown; Phase 3

Conditions: Colonoscopy

Treatments: Drug: 2 sachets of picosulfate; Drug: High volume split-dose PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT01685970

HGI-2012-09

Details and patient eligibility

About

Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Full description

Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms

Exclusion criteria

• pregnancy,
• breast feeding,
• prior history of surgical large bowel resection,
• severe medical condition such as severe cardiac,
• hepatic, or
• renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
• significant gastric paresis or gastric outlet obstruction or ileus,
• known or suspected bowel obstruction or perforation,
• drug addiction or major psychiatric illness,
• allergy to PEG and refusal to participate in the study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

High volume Split-dose PEG

Placebo Comparator group

Description:

Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation

Treatment:

Drug: High volume split-dose PEG

2 sachets of picosulfate

Active Comparator group

Description:

Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.

Treatment:

Drug: 2 sachets of picosulfate