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Completed

NCT Number: NCT02761213

Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

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Key information

Conditions

Cathartic Colon

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St. Mary's Hospital

Seoul, 137-040, South Korea

About this study

High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.

Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.

In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • people who receive colonoscopy
  • aged : 18-80
  • people who sign the consent

Exclusion criteria

  • those aged over 80 years
  • the disabled
  • intestinal obstruction
  • severe constipation
  • previous history of bowel resection
  • liver cirrhosis
  • heart failure or ischemic heart disease within 6 months
  • inflammatory bowel disease
  • pregnant women
  • severe renal insufficiency
  • people who refuse to sign the consent

Treatment and study plan

Oral sulfate solution (OSS)

Drug

Oral sulfate solution (OSS)

Other names: SUPREP

2-L PEG/Asc

Drug

Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.

Other names: COOLPREP

Primary outcomes

  1. Boston Bowel Preparation Scale (BPPS)

    Time frame: during colonoscopy

  2. Aronchick scale

    Time frame: during colonoscopy

    Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.

Secondary outcomes

  1. Tolerability by a patient questionnaire using 5-point Likert scale

    Time frame: on arrival at the endoscopy unit before colonoscopy

    to assess tolerability of each bowel preparation

  2. Safety by measuring hemodynamic and biochemical data

    Time frame: at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite

    Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness.

  3. Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers

    Time frame: during colonoscopy

  4. Percentage of cecal intubation

    Time frame: during colonoscopy

  5. Insertion time

    Time frame: during colonoscopy

  6. Withdrawal time

    Time frame: during colonoscopy

  7. Adenoma detection rate

    Time frame: during colonoscopy

Sponsors and collaborators

Lead sponsor

Bo-In Lee

Other

Collaborators

  • Pharmbio Korea Co., Ltd.

Registry information

Official study title

Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2016
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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