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

Phase 3

• Conditions: Colonoscopy
• Interventions: Drug: High volume split-dose PEG; Drug: 2 sachets of picosulfate

• Registration Number: NCT01685970
• Lead Sponsor: Inje University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Last Update Submitted: 2012-09-14
• Study First Posted: 2012-09-17
• Last Update Posted: 2012-09-17
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume Split-dose PEG	High volume split-dose PEG	Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
2 sachets of picosulfate	2 sachets of picosulfate	Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation	3 months	Quality of bowel preparation using Ottawa bowel preparation scale

Secondary Outcome Measures

Name	Time	Method
Tolerability	3 months	Tolerability of bowel preparation regimen is assessed by patient questionnaire.

Trial Locations

Locations (1)

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