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

Overview

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 Title of Study: “Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 2012

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.

Interventions

  • Drug: High volume split-dose PEG
    • High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
  • Drug: 2 sachets of picosulfate
    • 2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy

Arms, Groups and Cohorts

  • Placebo Comparator: High volume Split-dose PEG
    • Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
  • Active Comparator: 2 sachets of picosulfate
    • Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of bowel preparation
    • Time Frame: 3 months
    • Quality of bowel preparation using Ottawa bowel preparation scale

Secondary Measures

  • Tolerability
    • Time Frame: 3 months
    • Tolerability of bowel preparation regimen is assessed by patient questionnaire.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inje University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eun Hee Seo, MD, Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy – Inje University
  • Overall Official(s)
    • Tae Oh Kim, Ph D, Study Director, Haeundae Paik Hospital, Inje University College of Medicine
  • Overall Contact(s)
    • Tae Oh Kim, Ph D., 82-51-797-0658, kto0440@paik.ac.kr

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