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

September 14, 2012 updated by: Eun Hee Seo, MD, Inje University

Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Recruiting
        • Haeundae Paik Hospital, Inje University College of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eun Hee Seo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: High volume Split-dose PEG
Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
Drug: High volume split-dose PEG
High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
Other Names:
  • Polyethylene glycol(Colyte)
Active Comparator: 2 sachets of picosulfate
Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.
Drug: 2 sachets of picosulfate
2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
Other Names:
  • sodium picosulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation
Time Frame: 3 months
Quality of bowel preparation using Ottawa bowel preparation scale
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Study Director: Tae Oh Kim, Ph D, Haeundae Paik Hospital, Inje University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 17, 2012

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 14, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGI-2012-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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